FDA 510(k) Application Details - K955642

Device Classification Name Electrocardiograph

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510(K) Number K955642
Device Name Electrocardiograph
Applicant NELLCOR PURITAN BENNETT, INC.
11150 THOMPSON AVE.
LENEXA, KS 66219-2301 US
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Contact DAVID GREEN
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Regulation Number 870.2340

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Classification Product Code DPS
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Date Received 12/12/1995
Decision Date 07/02/1996
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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