The following data is part of a premarket notification filed by Concept, Inc. with the FDA for Arthroscan Video System.
Device ID | K834069 |
510k Number | K834069 |
Device Name: | ARTHROSCAN VIDEO SYSTEM |
Classification | Camera, Television, Endoscopic, Without Audio |
Applicant | CONCEPT, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FWF |
CFR Regulation Number | 878.4160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-11-25 |
Decision Date | 1984-01-27 |