FDA 510(k) Application Details - K022047

Device Classification Name Plethysmograph, Photoelectric, Pneumatic Or Hydraulic

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510(K) Number K022047
Device Name Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Applicant OSBORN MEDICAL CORP.
100 WEST MAIN
UTICA, MN 55979 US
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Contact BILL DAVIS
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Regulation Number 870.2780

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Classification Product Code JOM
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Date Received 06/24/2002
Decision Date 11/04/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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