FDA 510(k) Application Details - K071533

Device Classification Name Computer, Oxygen-Uptake

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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
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Regulation Number 868.1730

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Classification Product Code BZL
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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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