K820829 is an FDA 510(k) clearance for the MEDICAM. This device is classified as a Camera, Television, Surgical, Without Audio (Class I - General Controls, product code FWB).
Submitted by M.P. Video, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 3, 1982, 39 days after receiving the submission on March 25, 1982.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4160.
| 510(k) Number | K820829 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 25, 1982 |
| Decision Date | May 03, 1982 |
| Days to Decision | 39 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | FWB — Camera, Television, Surgical, Without Audio |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4160 |