FDA 510(k) Application Details - K002310

Device Classification Name Transmitters And Receivers, Electrocardiograph, Telephone

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510(K) Number K002310
Device Name Transmitters And Receivers, Electrocardiograph, Telephone
Applicant MERIDIAN MEDICAL TECHNOLOGIES LTD.
207 AIRPORT RD., WEST
BELFAST BT3 9ED IE
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Contact GERARD LYNN
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Regulation Number 870.2920

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Classification Product Code DXH
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Date Received 07/31/2000
Decision Date 10/25/2000
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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