Zymed Telemetry Monitor Model T8010 (Preliminary)
FDA 510(k) K924672 · Agilent Technologies
510(k) numberK924672
Submission
- Device name
- Zymed Telemetry Monitor Model T8010 (Preliminary)
- Applicant
- Agilent Technologies
Camarillo, CA, US - Received
- September 16, 1992
- Decision date
- December 15, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DSI – Detector And Alarm, Arrhythmia
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1025
- Specialty
- Cardiovascular
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Questions and answers
When was Zymed Telemetry Monitor Model T8010 (Preliminary) cleared by the FDA?
Zymed Telemetry Monitor Model T8010 (Preliminary) (K924672) received a 510(k) decision of Substantially Equivalent on December 15, 1992, 90 days after the submission was received.
What is the product code of K924672?
The FDA product code is DSI – Detector And Alarm, Arrhythmia, a Class II (moderate risk) device regulated under 21 CFR 870.1025.