Telemetry System XMT-1 & REC-1
FDA 510(k) K792371 · Burdick Corp.
510(k) numberK792371
Submission
- Device name
- Telemetry System XMT-1 & REC-1
- Applicant
- Burdick Corp.
Mchenry, IL, US - Received
- November 26, 1979
- Decision date
- January 31, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Telemetry System XMT-1 & REC-1 cleared by the FDA?
Telemetry System XMT-1 & REC-1 (K792371) received a 510(k) decision of Substantially Equivalent on January 31, 1980, 66 days after the submission was received.
What is the product code of K792371?
The FDA product code is GYE – Encephalogram Telemetry System, a Class II (moderate risk) device regulated under 21 CFR 882.1855.