510(k) K802657
K802657 is an FDA 510(k) premarket notification submitted by Telediagnostic Systems, Inc. for the device "MODEL AFR EEG TELEPHONE RECEIVER". The FDA issued a decision of Substantially Equivalent on November 12, 1980. The device falls under product code GYE (Encephalogram Telemetry System), a Class II device regulated under 21 CFR 882.1855. Telediagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 12, 1980
- Date Received
- October 24, 1980
- 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