The following data is part of a premarket notification filed by Clement Clarke, Inc. with the FDA for Opticom M600.
Device ID | K932258 |
510k Number | K932258 |
Device Name: | OPTICOM M600 |
Classification | Perimeter, Automatic, Ac-powered |
Applicant | CLEMENT CLARKE, INC. 3128 EAST 17TH.AVENUE UNIT D Columbus, OH 43219 |
Contact | Thomas Lehman |
Correspondent | Thomas Lehman CLEMENT CLARKE, INC. 3128 EAST 17TH.AVENUE UNIT D Columbus, OH 43219 |
Product Code | HPT |
CFR Regulation Number | 886.1605 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-05-10 |
Decision Date | 1994-07-25 |