The following data is part of a premarket notification filed by Chattanooga Group, Inc. with the FDA for Electro-goniometer.
Device ID | K812908 |
510k Number | K812908 |
Device Name: | ELECTRO-GONIOMETER |
Classification | Goniometer, Ac-powered |
Applicant | CHATTANOOGA GROUP, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | KQX |
CFR Regulation Number | 888.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-10-19 |
Decision Date | 1981-11-24 |