The following data is part of a premarket notification filed by Medical Dynamics, Inc. with the FDA for Medical Dynamics Solid State Video Camera 5940.
| Device ID | K884039 |
| 510k Number | K884039 |
| Device Name: | MEDICAL DYNAMICS SOLID STATE VIDEO CAMERA 5940 |
| Classification | Camera, Cine, Surgical, Without Audio |
| Applicant | MEDICAL DYNAMICS, INC. 99 INVERNESS DR., EAST Englewood, CO 80112 |
| Contact | Jo Brehm |
| Correspondent | Jo Brehm MEDICAL DYNAMICS, INC. 99 INVERNESS DR., EAST Englewood, CO 80112 |
| Product Code | FWH |
| CFR Regulation Number | 878.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-26 |
| Decision Date | 1988-10-13 |