FDA 510(k) Application Details - K022073

Device Classification Name Transmitters And Receivers, Electrocardiograph, Telephone

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510(K) Number K022073
Device Name Transmitters And Receivers, Electrocardiograph, Telephone
Applicant AEROTEL MEDICAL SYSTEMS (1998) LTD.
377ROUTE 17 S
HASBROUCK HEIGHT, NJ 07604 US
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Contact GEORGE MYERS
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Regulation Number 870.2920

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Classification Product Code DXH
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Date Received 06/26/2002
Decision Date 07/24/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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