The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Bf 240/p240/it240 Bronchovideoscope & Accessories.
| Device ID | K963033 |
| 510k Number | K963033 |
| Device Name: | BF 240/P240/IT240 BRONCHOVIDEOSCOPE & ACCESSORIES |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Contact | Barry E Sands |
| Correspondent | Barry E Sands OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-05 |
| Decision Date | 1996-09-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14953170370615 | K963033 | 000 |
| 04953170355288 | K963033 | 000 |
| 04953170318320 | K963033 | 000 |
| 04953170286438 | K963033 | 000 |
| 04953170144011 | K963033 | 000 |
| 04953170071386 | K963033 | 000 |
| 04953170060748 | K963033 | 000 |