The following data is part of a premarket notification filed by Olympus Corp. with the FDA for Bronchoscope Bf-n20.
| Device ID | K910423 |
| 510k Number | K910423 |
| Device Name: | BRONCHOSCOPE BF-N20 |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
| Contact | Daniel Dillon |
| Correspondent | Daniel Dillon OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-30 |
| Decision Date | 1991-04-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170071591 | K910423 | 000 |
| 04953170064685 | K910423 | 000 |
| 04953170063954 | K910423 | 000 |
| 04953170051142 | K910423 | 000 |
| 04953170442667 | K910423 | 000 |