FDA 510(k) Application Details - K982499

Device Classification Name Calculator, Pulmonary Function Data

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510(K) Number K982499
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
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Regulation Number 868.1880

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Classification Product Code BZC
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Date Received 07/20/1998
Decision Date 10/16/1998
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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