The following data is part of a premarket notification filed by Instrumentation Camera, Inc. with the FDA for 105mm Spot Film Camera.
Device ID | K802132 |
510k Number | K802132 |
Device Name: | 105MM SPOT FILM CAMERA |
Classification | Camera, X-ray, Fluorographic, Cine Or Spot |
Applicant | INSTRUMENTATION CAMERA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IZJ |
CFR Regulation Number | 892.1620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-09-03 |
Decision Date | 1980-10-23 |