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FDA 510(k) Application Details - K954730
Device Classification Name
Calculator, Pulmonary Function Data
More FDA Info for this Device
510(K) Number
K954730
Device Name
Calculator, Pulmonary Function Data
Applicant
P.K. MORGAN LTD.
4 BLOORS LANE
KENT RAINHAM ME8 7ED GB
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Contact
R. H JKERNAGHAN
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Regulation Number
868.1880
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Classification Product Code
BZC
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More FDA Info for this Product Code
Date Received
10/16/1995
Decision Date
04/01/1997
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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