510(k) K813010

EEG TELEPHONE TRANSMITTER, MODEL #T-7 by Pharmaquest Corp. — Product Code GYE

K813010 is an FDA 510(k) premarket notification submitted by Pharmaquest Corp. for the device "EEG TELEPHONE TRANSMITTER, MODEL #T-7". The FDA issued a decision of Substantially Equivalent on November 16, 1981. The device falls under product code GYE (Encephalogram Telemetry System), a Class II device regulated under 21 CFR 882.1855. Pharmaquest Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1981
Date Received
October 27, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Encephalogram Telemetry System
Device Class
Class II
Regulation Number
882.1855
Review Panel
NE
Submission Type