The following data is part of a premarket notification filed by Vistek Corp. with the FDA for Vis-1000 Video System.
Device ID | K843806 |
510k Number | K843806 |
Device Name: | VIS-1000 VIDEO SYSTEM |
Classification | Camera, Surgical And Accessories |
Applicant | VISTEK CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Contact | Mark R Collins |
Correspondent | Mark R Collins VISTEK CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KQM |
CFR Regulation Number | 878.4160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-09-27 |
Decision Date | 1984-12-12 |