The following data is part of a premarket notification filed by Medical Dynamics, Inc. with the FDA for Fdx Solid State Video Camera Model 5950.
Device ID | K891236 |
510k Number | K891236 |
Device Name: | FDX SOLID STATE VIDEO CAMERA MODEL 5950 |
Classification | Camera, Television, Microsurgical, 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 | FWD |
CFR Regulation Number | 878.4160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-03-07 |
Decision Date | 1989-04-05 |