The following data is part of a premarket notification filed by Concept, Inc. with the FDA for Concept Video Imaging System.
| Device ID | K850749 |
| 510k Number | K850749 |
| Device Name: | CONCEPT VIDEO IMAGING SYSTEM |
| Classification | Camera, Surgical And Accessories |
| Applicant | CONCEPT, INC. 12707 U.S. 19 SOUTH Clearwater, FL 33546 |
| Contact | Penny C Rasmussen |
| Correspondent | Penny C Rasmussen CONCEPT, INC. 12707 U.S. 19 SOUTH Clearwater, FL 33546 |
| Product Code | KQM |
| CFR Regulation Number | 878.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-25 |
| Decision Date | 1985-05-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20845854038571 | K850749 | 000 |
| 20845854038564 | K850749 | 000 |
| 20845854038557 | K850749 | 000 |
| 20845854038540 | K850749 | 000 |
| 20845854018030 | K850749 | 000 |
| 20845854016692 | K850749 | 000 |
| 20845854013233 | K850749 | 000 |