FDA 510(k) Application Details - K874326

Device Classification Name Electrocardiograph

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510(K) Number K874326
Device Name Electrocardiograph
Applicant AIR-SHIELDS, INC.
330 JACKSONVILLE RD.
HATBORO, PA US
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Contact FRANCIS X CASEY
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Regulation Number 870.2340

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Classification Product Code DPS
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Date Received 10/21/1987
Decision Date 12/05/1988
Decision SE - Substantially Equivalent
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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