The following data is part of a premarket notification filed by Angiolaz, Inc. with the FDA for Ves 0281-m Complete Video Endoscopic Video System.
| Device ID | K981827 |
| 510k Number | K981827 |
| Device Name: | VES 0281-M COMPLETE VIDEO ENDOSCOPIC VIDEO SYSTEM |
| Classification | Endoscopic Video Imaging System/component, Gastroenterology-urology |
| Applicant | ANGIOLAZ, INC. P.O. BOX 556 INDUSTRIAL PARK Bellows Falls, VT 05101 |
| Contact | John D Plumadore |
| Correspondent | John D Plumadore ANGIOLAZ, INC. P.O. BOX 556 INDUSTRIAL PARK Bellows Falls, VT 05101 |
| Product Code | FET |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-22 |
| Decision Date | 1998-07-28 |
| Summary: | summary |