The following data is part of a premarket notification filed by Vistek Corp. with the FDA for Vis-2000 Video System.
Device ID | K860173 |
510k Number | K860173 |
Device Name: | VIS-2000 VIDEO SYSTEM |
Classification | Camera, Television, Endoscopic, With Audio |
Applicant | VISTEK CORP. 4 EAST YANONALI ST. Santa Barbara, CA 93101 |
Contact | Mark R Collins |
Correspondent | Mark R Collins VISTEK CORP. 4 EAST YANONALI ST. Santa Barbara, CA 93101 |
Product Code | FWG |
CFR Regulation Number | 878.4160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-01-17 |
Decision Date | 1986-02-07 |