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FDA 510(k) Application Details - K964360
Device Classification Name
Calculator, Pulmonary Function Data
More FDA Info for this Device
510(K) Number
K964360
Device Name
Calculator, Pulmonary Function Data
Applicant
NOVAMETRIX MEDICAL SYSTEMS, INC.
56 CARPENTER LN.
WALLINGFORD, CT 06492 US
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Contact
ROBERT H SCHIFFMAN, R.A.C.
Other 510(k) Applications for this Contact
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
11/01/1996
Decision Date
04/04/1997
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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