The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medical Dynamics Ccd Solid State Video Camera 5930.
Device ID | K855020 |
510k Number | K855020 |
Device Name: | MEDICAL DYNAMICS CCD SOLID STATE VIDEO CAMERA 5930 |
Classification | Camera, Television, Surgical, Without Audio |
Applicant | MEDLINE INDUSTRIES, INC. 99 INVERNESS DRIVE EAST Englewood, CO 80112 |
Contact | Jo Brehm |
Correspondent | Jo Brehm MEDLINE INDUSTRIES, INC. 99 INVERNESS DRIVE EAST Englewood, CO 80112 |
Product Code | FWB |
CFR Regulation Number | 878.4160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-12-16 |
Decision Date | 1986-01-24 |