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FDA 510(k) Application Details - K071533
Device Classification Name
Computer, Oxygen-Uptake
More FDA Info for this Device
510(K) Number
K071533
Device Name
Computer, Oxygen-Uptake
Applicant
COSMED S.R.L.
1129 BLOOMFIELD AVENUE
WEST CALDWELL, NJ 07000 US
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Contact
ROBERT SCHIFF
Other 510(k) Applications for this Contact
Regulation Number
868.1730
More FDA Info for this Regulation Number
Classification Product Code
BZL
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More FDA Info for this Product Code
Date Received
06/05/2007
Decision Date
09/28/2007
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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