The following data is part of a premarket notification filed by Angiolaz, Inc. with the FDA for Angiolaz Ves-1cam.
Device ID | K981819 |
510k Number | K981819 |
Device Name: | ANGIOLAZ VES-1CAM |
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 | 1998-05-22 |
Decision Date | 1998-08-04 |