The following data is part of a premarket notification filed by Medical Devices, Inc. with the FDA for Video Camera W/ Electronic Shutter Model Vce-10.
Device ID | K930053 |
510k Number | K930053 |
Device Name: | VIDEO CAMERA W/ ELECTRONIC SHUTTER MODEL VCE-10 |
Classification | Camera, Television, Endoscopic, Without Audio |
Applicant | MEDICAL DEVICES, INC. 83 HOBART ST. Hackensack, NJ 07601 |
Contact | Samuel Dickstein |
Correspondent | Samuel Dickstein MEDICAL DEVICES, INC. 83 HOBART ST. Hackensack, NJ 07601 |
Product Code | FWF |
CFR Regulation Number | 878.4160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-01-06 |
Decision Date | 1993-05-17 |