The following data is part of a premarket notification filed by Kamiya Tsusan Kaisha, Ltd. with the FDA for Endoscopic Camera Tv W/audio.
Device ID | K832342 |
510k Number | K832342 |
Device Name: | ENDOSCOPIC CAMERA TV W/AUDIO |
Classification | Camera, Surgical And Accessories |
Applicant | KAMIYA TSUSAN KAISHA, LTD. CPO BOX 1590 TOKYO 100-91 JAPAN , |
Product Code | KQM |
CFR Regulation Number | 878.4160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-07-12 |
Decision Date | 1983-09-12 |