510(k) K833236

TELEPHONE TRANSMITTER T-10 EEG by Pharmaquest Corp. — Product Code GYE

K833236 is an FDA 510(k) premarket notification submitted by Pharmaquest Corp. for the device "TELEPHONE TRANSMITTER T-10 EEG". The FDA issued a decision of Substantially Equivalent on November 29, 1983. 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 29, 1983
Date Received
August 16, 1983
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