510(k) K813010
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