FDA 510(k) Application Details - K952542

Device Classification Name Calculator, Pulmonary Function Data

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510(K) Number K952542
Device Name Calculator, Pulmonary Function Data
Applicant ACKRAD LABORATORIES
70 JACKSON DR.
CRANFORD, NJ 07016 US
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Contact ROBERT M LANDIS
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Regulation Number 868.1880

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Classification Product Code BZC
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Date Received 05/23/1995
Decision Date 04/23/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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