The following data is part of a premarket notification filed by Olympus Optical Co., Ltd. with the FDA for Evis Exera Bronchofibervideoscope Olympus Bf Type Xp160f, Its Accessories And Ancillary Equipment.
| Device ID | K033225 |
| 510k Number | K033225 |
| Device Name: | EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND ANCILLARY EQUIPMENT |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | OLYMPUS OPTICAL CO., LTD. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Contact | Tina Steffanie-oak |
| Correspondent | Ned E Devine ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-10-06 |
| Decision Date | 2003-10-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170340116 | K033225 | 000 |
| 04953170340093 | K033225 | 000 |
| 04953170340048 | K033225 | 000 |
| 04953170289064 | K033225 | 000 |
| 04953170289033 | K033225 | 000 |