The following data is part of a premarket notification filed by Chattanooga Group, Inc. with the FDA for Kc/emg Diagnostic Electromyograph.
Device ID | K864630 |
510k Number | K864630 |
Device Name: | KC/EMG DIAGNOSTIC ELECTROMYOGRAPH |
Classification | Electromyograph, Diagnostic |
Applicant | CHATTANOOGA GROUP, INC. 101 MEMORIAL DR. Red Bank, TN 37405 |
Contact | Bill Cheal |
Correspondent | Bill Cheal CHATTANOOGA GROUP, INC. 101 MEMORIAL DR. Red Bank, TN 37405 |
Product Code | IKN |
CFR Regulation Number | 890.1375 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-11-25 |
Decision Date | 1986-12-29 |