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FDA 510(k) Application Details - K963400
Device Classification Name
Electrocardiograph
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510(K) Number
K963400
Device Name
Electrocardiograph
Applicant
NELLCOR PURITAN BENNETT, INC.
11150 THOMPSON AVE.
LENEXA, KS 66219-2301 US
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DAVID A GREEN
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Regulation Number
870.2340
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Classification Product Code
DPS
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More FDA Info for this Product Code
Date Received
08/29/1996
Decision Date
11/26/1996
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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