K982397 is an FDA 510(k) clearance for the VES 3001-M COMPLETE VIDEO ENDOSCOPIC SYSTEM. This device is classified as a Camera, Television, Endoscopic, Without Audio (Class I - General Controls, product code FWF).
Submitted by Angiolaz, Inc. (Bellows Falls, US). The FDA issued a Cleared decision on September 10, 1998, 63 days after receiving the submission on July 9, 1998.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4160.
| 510(k) Number | K982397 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 09, 1998 |
| Decision Date | September 10, 1998 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | FWF — Camera, Television, Endoscopic, Without Audio |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4160 |