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FDA 510(k) Application Details - K001631
Device Classification Name
Calculator, Pulmonary Function Data
More FDA Info for this Device
510(K) Number
K001631
Device Name
Calculator, Pulmonary Function Data
Applicant
CORTEX BIOPHYSIK GMBH
962 ALLEGRO LN.
APOLLO BEACH, FL 33572 US
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Contact
ART WARD
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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
05/26/2000
Decision Date
02/22/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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