The following data is part of a premarket notification filed by Pharmaquest Corp. with the FDA for Eeg Telephone Transmitter, Model #t-7.
Device ID | K813010 |
510k Number | K813010 |
Device Name: | EEG TELEPHONE TRANSMITTER, MODEL #T-7 |
Classification | Encephalogram Telemetry System |
Applicant | PHARMAQUEST CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GYE |
CFR Regulation Number | 882.1855 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-10-27 |
Decision Date | 1981-11-16 |