The following data is part of a premarket notification filed by Concept, Inc. with the FDA for Esa Camera.
| Device ID | K823516 |
| 510k Number | K823516 |
| Device Name: | ESA CAMERA |
| Classification | Camera, Cine, Surgical, Without Audio |
| Applicant | CONCEPT, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FWH |
| CFR Regulation Number | 878.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-11-29 |
| Decision Date | 1982-12-30 |