Telephone Transmitter T-10 EEG
FDA 510(k) K833236 · Pharmaquest Corp.
510(k) numberK833236
Submission
- Device name
- Telephone Transmitter T-10 EEG
- Applicant
- Pharmaquest Corp.
Walker, MI, US - Received
- August 16, 1983
- Decision date
- November 29, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Telephone Transmitter T-10 EEG cleared by the FDA?
Telephone Transmitter T-10 EEG (K833236) received a 510(k) decision of Substantially Equivalent on November 29, 1983, 105 days after the submission was received.
What is the product code of K833236?
The FDA product code is GYE – Encephalogram Telemetry System, a Class II (moderate risk) device regulated under 21 CFR 882.1855.