The following data is part of a premarket notification filed by Olympus Corp. with the FDA for Evis 200 System.
| Device ID | K931154 |
| 510k Number | K931154 |
| Device Name: | EVIS 200 SYSTEM |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
| Contact | Barry E Sands |
| Correspondent | Barry E Sands 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 | 1993-03-08 |
| Decision Date | 1993-10-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14953170152822 | K931154 | 000 |
| 14953170049405 | K931154 | 000 |
| 14953170049382 | K931154 | 000 |
| 14953170049368 | K931154 | 000 |
| 14953170049344 | K931154 | 000 |
| 04953170026881 | K931154 | 000 |
| 04953170026591 | K931154 | 000 |