Product Code: KZF
FDA class 1
21 CFR 880.6320
Device, Medical Examination, Ac Powered
General Hospital
The AC-Powered Medical Examination Device is a powered general-purpose instrument used for patient examination in clinical settings, encompassing a variety of examination aids or diagnostic tools that require alternating current for operation. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, with no premarket submission required. The product code is KZF, regulated under 21 CFR 880.6320, in the General Hospital medical specialty. No special flags apply to this device.
510(k)s
37
FEI Numbers
89
Registration Numbers
89
Unique Applicants
18
Years Active
18
Basic Information
- Product Code
- KZF
- Device Class
- FDA class 1
- Regulation Number
- 880.6320
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 37 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K954943 | NEVOSCOPE | Mar 27, 1996 | Substantially Equivalent | NIZAR A. MULLANI |
| K952835 | WELCH ALLYN VIDEO EPISCOPE | Sep 22, 1995 | Substantially Equivalent | WELCH ALLYN, INC. |
| K945507 | H 5100, H 5200, H 5300 | Dec 09, 1994 | Substantially Equivalent | RUDOLF RIESTER GMBH & CO. KG |
| K941869 | SPLINT, PNEUMATIC, ARM & SPLINT, PNEUMATIC, LEG | Aug 03, 1994 | Substantially Equivalent | THE LIGHTHOUSE FOR THE BLIND, INC. |
| K936088 | WAVE FLUORESCENT MAGNIFIER | Apr 26, 1994 | Substantially Equivalent | BURTON MEDICAL PRODUCTS CORP. |
| K940284 | MEDDEV MULTARRAY MEDICAL EXAMINING LIGHT MODIFICATION | Feb 28, 1994 | Substantially Equivalent | MEDDEV INTERNATIONAL CORP. |
| K933564 | SKYTRON EXAM LIGHT | Feb 10, 1994 | Substantially Equivalent | SKYTRON, DIV. THE KMW GROUP, INC. |
| K935832 | CHROMOPHARE | Feb 03, 1994 | Substantially Equivalent | BERCHTOLD HOLDING GMBH |
| K934259 | AC-POWERED MEDICAL EXAMINATION LIGHT | Jan 28, 1994 | Substantially Equivalent | WELCH ALLYN, INC. |
| K932719 | RITTER MODEL 158 AND 159 EXAM LIGHTS | Dec 02, 1993 | Substantially Equivalent | MIDMARK CORP. |
| K924447 | VITAPEN | Sep 27, 1993 | Substantially Equivalent | VITAJET CORP. |
| K931197 | MEDDEV MULTARRAY (TM) MEDICAL EXAMINATION LIGHT | Sep 23, 1993 | Substantially Equivalent | MEDDEV INTERNATIONAL CORP. |
| K931645 | HALUX TASKLIGHT | Aug 20, 1993 | Substantially Equivalent | BURTON MEDICAL PRODUCTS CORP. |
| K931646 | MI-4 VARIABLE SPOT LIGHT | Aug 19, 1993 | Substantially Equivalent | MEDICAL ILLUMINATION, INC. |
| K931026 | MI-5 DIAGNOSTIC LIGHT | Aug 19, 1993 | Substantially Equivalent | MEDICAL ILLUMINATION, INC. |
| K925710 | M.E.D. LIGHT | Jun 04, 1993 | Substantially Equivalent | MEDICAL ILLUMINATION, INC. |
| K922282 | ILLUMINATOR VIII ULTRA/SPOT | Mar 04, 1993 | Substantially Equivalent | MEDICAL ILLUMINATION, INC. |
| K922278 | ILLUMINATOR III | Mar 04, 1993 | Substantially Equivalent | MEDICAL ILLUMINATION, INC. |
| K922281 | ILLUMINATOR VII MINI/SPOT LIGHT | Feb 05, 1993 | Substantially Equivalent | MEDICAL ILLUMINATION, INC. |
| K922280 | ILLUMINATOR VII MINI/LUM LIGHT | Feb 05, 1993 | Substantially Equivalent | MEDICAL ILLUMINATION, INC. |
| K922277 | ILLUMINATOR II | Feb 05, 1993 | Substantially Equivalent | MEDICAL ILLUMINATION, INC. |
| K921493 | LS100 HALOGEN EXAMINATION LIGHT, MODEL NO: 44100 | Nov 03, 1992 | Substantially Equivalent | WELCH ALLYN, INC. |
| K922150 | EXAMINATION LAMP | Jul 21, 1992 | Substantially Equivalent | AIR-SHIELDS, INC. |
| K920103 | EPISCOPE, MODEL 47300 | Apr 28, 1992 | Substantially Equivalent | WELCH ALLYN, INC. |
| K901706 | LIGHT, HEAD, EXAMINATION | Jul 19, 1990 | Substantially Equivalent | BURTON MEDICAL PRODUCTS CORP. |
| K896611 | OLYMPIC LIGHT-WARM | Feb 06, 1990 | Substantially Equivalent | OLYMPIC MEDICAL CORP. |
| K896962 | TINY HALOGEN EXAM LIGHT | Dec 29, 1989 | Substantially Equivalent | JEDMED INSTRUMENT CO. |
| K893808 | MODEL 0450000, OPAL MEDICAL EXAM LIGHT | Aug 15, 1989 | Substantially Equivalent | BURTON MEDICAL PRODUCTS CORP. |
| K893807 | MODEL 0183010, PEARL MEDICAL EXAM LIGHT | Aug 15, 1989 | Substantially Equivalent | BURTON MEDICAL PRODUCTS CORP. |
| K861289 | BASIC LIGHT | Apr 18, 1986 | Substantially Equivalent | BURTON MEDICAL PRODUCTS CORP. |
| K852949 | WELCH ALLYN #48100 TASK LITE W/ACCESSORIES AS LIST | Sep 04, 1985 | Substantially Equivalent | WELCH ALLYN, INC. |
| K851742 | MEDICAL EXAMINATION LIGHTS | May 13, 1985 | Substantially Equivalent | BURTON MEDICAL PRODUCTS CORP. |
| K842135 | HI-LO FLOOR STANDING EXAM. LIGHT | Jul 06, 1984 | Substantially Equivalent | GOOD-LITE CO. |
| K812142 | LIC 180 MEDICAL LAMPS | Aug 13, 1981 | Substantially Equivalent | LADA INTL., INC. |
| K800067 | VITA LAMP, MODEL 0350 | May 08, 1980 | Substantially Equivalent | TENSOR INDUSTRIES, INC. |
| K800230 | ABCO EXAMINATION LAMP (GOOSENECK TYPE) | Feb 26, 1980 | Substantially Equivalent | ABCO DEALERS, INC. |
| K780628 | HALOGEN EXAM. LITE #48400 | Jun 06, 1978 | Substantially Equivalent | WELCH ALLYN, INC. |
FEI Numbers
This FDA classification entry is associated with 89 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 89 registration numbers. Click on an entry to view related FDA registrations.