K855020 is an FDA 510(k) clearance for the MEDICAL DYNAMICS CCD SOLID STATE VIDEO CAMERA 5930. This device is classified as a Camera, Television, Surgical, Without Audio (Class I - General Controls, product code FWB).
Submitted by Medline Industries, Inc. (Englewood, US). The FDA issued a Cleared decision on January 24, 1986, 39 days after receiving the submission on December 16, 1985.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4160.
| 510(k) Number | K855020 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 16, 1985 |
| Decision Date | January 24, 1986 |
| 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 |