FDA 510(k) Application Details - K982487

Device Classification Name Calculator, Pulmonary Function Data

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510(K) Number K982487
Device Name Calculator, Pulmonary Function Data
Applicant CARDIOPULMONARY TECHNOLOGIES, INC.
W 260 N 9311 HIGHWAY 164
COLGATE, WI 53017-9600 US
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Contact MARK S STORSVED
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Regulation Number 868.1880

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Classification Product Code BZC
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Date Received 07/17/1998
Decision Date 10/14/1998
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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