The following data is part of a premarket notification filed by Innovative Medical Devices, Inc. with the FDA for Imd Multicam 1000/2000 Video Camera Systems.
Device ID | K912531 |
510k Number | K912531 |
Device Name: | IMD MULTICAM 1000/2000 VIDEO CAMERA SYSTEMS |
Classification | Endoscopic Video Imaging System/component, Gastroenterology-urology |
Applicant | INNOVATIVE MEDICAL DEVICES, INC. 1637 GRAND RD. Mountain View, CA 94040 |
Contact | Alan Peck |
Correspondent | Alan Peck INNOVATIVE MEDICAL DEVICES, INC. 1637 GRAND RD. Mountain View, CA 94040 |
Product Code | FET |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-06-07 |
Decision Date | 1991-09-04 |