FDA 510(k) Application Details - K002089

Device Classification Name Transmitters And Receivers, Physiological Signal, Radiofrequency

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510(K) Number K002089
Device Name Transmitters And Receivers, Physiological Signal, Radiofrequency
Applicant GENERAL DEVICES
1000 RIVER ST.
RIDGEFIELD, NJ 07657 US
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Contact MICHAEL SMITH
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Regulation Number 870.2910

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Classification Product Code DRG
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Date Received 07/11/2000
Decision Date 11/21/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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