BRONCHOSCOPE BF-N20
FDA 510(k) clearance K910423 · decided 1991-04-29
Clearance details
- K-number
- K910423
- Device name
- BRONCHOSCOPE BF-N20
- Applicant
- Olympus Corp.
- Decision
- Substantially Equivalent
- Date received
- 1991-01-30
- Decision date
- 1991-04-29
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- EOQ
- Device class
- 2
- Regulation number
- 874.4680
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Lake Success, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Olympus Bronchovideoscope, Models BF-3C40 & BF-N20. recall (Z-2502-2023) | Olympus Corporation of the Americas | 2023-08-31 |