The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Oes Otv-s5c Video System.
| Device ID | K971416 |
| 510k Number | K971416 |
| Device Name: | OLYMPUS OES OTV-S5C VIDEO SYSTEM |
| Classification | Endoscopic Video Imaging System/component, Gastroenterology-urology |
| Applicant | OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Contact | Subhash R Patel |
| Correspondent | Subhash R Patel OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Product Code | FET |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-16 |
| Decision Date | 1997-07-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170023972 | K971416 | 000 |
| 04953170023910 | K971416 | 000 |
| 04953170023804 | K971416 | 000 |
| 04953170023729 | K971416 | 000 |
| 04953170023422 | K971416 | 000 |
| 04953170023392 | K971416 | 000 |