The following data is part of a premarket notification filed by Pharmaquest Corp. with the FDA for Telephone Transmitter T-10 Eeg.
Device ID | K833236 |
510k Number | K833236 |
Device Name: | TELEPHONE TRANSMITTER T-10 EEG |
Classification | Encephalogram Telemetry System |
Applicant | PHARMAQUEST CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | GYE |
CFR Regulation Number | 882.1855 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-08-16 |
Decision Date | 1983-11-29 |