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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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MARK S STORSVED
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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
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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