The following data is part of a premarket notification filed by Fujinon, Inc. with the FDA for Bronchoscope.
| Device ID | K954707 |
| 510k Number | K954707 |
| Device Name: | BRONCHOSCOPE |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | FUJINON, INC. 399 PARK AVE. New York, NY 10022 -4689 |
| Contact | Gary A Adler |
| Correspondent | Gary A Adler FUJINON, INC. 399 PARK AVE. New York, NY 10022 -4689 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-12 |
| Decision Date | 1995-11-22 |