The following data is part of a premarket notification filed by The Olympus Optical Co. with the FDA for Modification To Olympus Bronchoscopes Bf-40 Series, Bf-240 Series, And Bf-160 Series.
| Device ID | K023984 |
| 510k Number | K023984 |
| Device Name: | MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160 SERIES |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | THE OLYMPUS OPTICAL CO. TWO CORPORATE DR. Melville, NY 11747 |
| Contact | Laura Storms-tyler |
| Correspondent | Laura Storms-tyler THE OLYMPUS OPTICAL CO. TWO CORPORATE DR. Melville, NY 11747 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-02 |
| Decision Date | 2003-01-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170340246 | K023984 | 000 |
| 04953170308161 | K023984 | 000 |
| 04953170308154 | K023984 | 000 |
| 04953170308130 | K023984 | 000 |
| 04953170308123 | K023984 | 000 |
| 04953170288968 | K023984 | 000 |
| 04953170288876 | K023984 | 000 |
| 04953170156250 | K023984 | 000 |
| 04953170063039 | K023984 | 000 |
| 04953170063008 | K023984 | 000 |
| 04953170308178 | K023984 | 000 |
| 04953170308185 | K023984 | 000 |
| 04953170308277 | K023984 | 000 |
| 04953170340147 | K023984 | 000 |
| 04953170340031 | K023984 | 000 |
| 04953170339998 | K023984 | 000 |
| 04953170339974 | K023984 | 000 |
| 04953170339394 | K023984 | 000 |
| 04953170339264 | K023984 | 000 |
| 04953170339240 | K023984 | 000 |
| 04953170339219 | K023984 | 000 |
| 04953170339196 | K023984 | 000 |
| 04953170062988 | K023984 | 000 |