FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LIGHT, HEAD, EXAMINATION
K Number: K901706
·
Decision Jul 19, 1990
Classifications
1
FEI Numbers
90
Registration Numbers
90
Same Product Code
36
Applicant Total
15
Review Days
98
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- LIGHT, HEAD, EXAMINATION
- K Number
- K901706
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6320
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Burton Medical Products Corp.
- Date Received
- April 12, 1990
- Decision Date
- July 19, 1990
- Product Code
- KZF
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KZF | Device, Medical Examination, Ac Powered | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KZF), ordered by most recent decision date.
NEVOSCOPE
FDA 510(k)
FDA Class 1
·General Hospital
WELCH ALLYN VIDEO EPISCOPE
FDA 510(k)
FDA Class 1
·General Hospital
H 5100, H 5200, H 5300
FDA 510(k)
FDA Class 1
·General Hospital
SPLINT, PNEUMATIC, ARM & SPLINT, PNEUMATIC, LEG
FDA 510(k)
FDA Class 1
·General Hospital
WAVE FLUORESCENT MAGNIFIER
FDA 510(k)
FDA Class 1
·General Hospital
MEDDEV MULTARRAY MEDICAL EXAMINING LIGHT MODIFICATION
FDA 510(k)
FDA Class 1
·General Hospital
Other Clearances by Burton Medical Products Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K101537 | AIM 200, MAJOR SURGICAL LIGHT | Sep 30, 2010 | Substantially Equivalent |
| K042395 | OUTPATIENT III MINOR SURGERY LIGHT | Dec 1, 2004 | Substantially Equivalent |
| K000639 | VISIONARY 2000 | May 25, 2000 | Substantially Equivalent |
| K963682 | GENIE' SINGLE CEILING AND DOUBLE CEILING | Nov 13, 1996 | Substantially Equivalent |
| K961843 | GENIE | Aug 22, 1996 | Substantially Equivalent |
| K935102 | SATURN LIGHT | Jun 27, 1994 | Substantially Equivalent |
| K942553 | GENESIS | Jun 23, 1994 | Substantially Equivalent |
| K936088 | WAVE FLUORESCENT MAGNIFIER | Apr 26, 1994 | Substantially Equivalent |
| K931645 | HALUX TASKLIGHT | Aug 20, 1993 | Substantially Equivalent |
| K893807 | MODEL 0183010, PEARL MEDICAL EXAM LIGHT | Aug 15, 1989 | Substantially Equivalent |