The following data is part of a premarket notification filed by Angiolaz, Inc. with the FDA for Ves 3001-m Complete Video Endoscopic System.
| Device ID | K982397 |
| 510k Number | K982397 |
| Device Name: | VES 3001-M COMPLETE VIDEO ENDOSCOPIC SYSTEM |
| Classification | Camera, Television, Endoscopic, Without Audio |
| Applicant | ANGIOLAZ, INC. INDUSTRIAL PARK Bellows Falls, VT 05101 -0556 |
| Contact | John D Plumadore |
| Correspondent | John D Plumadore ANGIOLAZ, INC. INDUSTRIAL PARK Bellows Falls, VT 05101 -0556 |
| Product Code | FWF |
| CFR Regulation Number | 878.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-09 |
| Decision Date | 1998-09-10 |