FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OP-CON SURG. INSTRUMENT #7
K Number: K834172
·
Decision Mar 6, 1984
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
20
Applicant Total
52
Review Days
106
Basic Information
- Device Name
- OP-CON SURG. INSTRUMENT #7
- K Number
- K834172
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4760
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- IMM ENTERPRISES LTD.
- Date Received
- November 21, 1983
- Decision Date
- March 6, 1984
- Product Code
- EQN
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| EQN | Laryngoscope, Nasopharyngoscope | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EQN), ordered by most recent decision date.
ORL Video NasoPharyngo-Larngoscope
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
LARYNGOSCOPE ATTACHMENT PH2000
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
COOL-LITE FIBERCOPTIC LARYNGEAL EXAM
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
LARYNGOSCOPES RIGID
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
NAGASHIMA NX-150F LIGHT SOURCE UNIT
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Other Clearances by IMM ENTERPRISES LTD.
| K Number | Device Name | ||
|---|---|---|---|
| K841386 | KOLLMANN URETHRAL DILATOR | May 9, 1984 | Substantially Equivalent |
| K840311 | CAT. 7-EAR, NOSE & THROAT DEVICES | May 9, 1984 | Substantially Equivalent |
| K841387 | WESTON RECTAL SNARE | May 9, 1984 | Substantially Equivalent |
| K840304 | CATEGORY 17-MICROBIOLOGY DEVICES | May 1, 1984 | Substantially Equivalent |
| K840305 | CATEGORY 1 CIRCULATORY SYSTEM DEVICE | Apr 23, 1984 | Substantially Equivalent |
| K840318 | CAT. 14-CLINICAL TOXIOLOGY DEVICES | Apr 23, 1984 | Substantially Equivalent |
| K840312 | CAT. 8 DENTAL DEVICES | Apr 5, 1984 | Substantially Equivalent |
| K834171 | OP-CON SURG. INSTRUMENT #3 | Apr 4, 1984 | Substantially Equivalent |
| K834192 | JAKOBI SURG. INSTRUMENTS #3 21/22/24 | Mar 22, 1984 | Substantially Equivalent |
| K834191 | JAKOBI SURGICAL INSTRUMENTS #3 17/18/19 | Mar 22, 1984 | Substantially Equivalent |