FDA 510(k) Application Details - K973659

Device Classification Name Plethysmograph, Photoelectric, Pneumatic Or Hydraulic

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510(K) Number K973659
Device Name Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Applicant VASOCOR, INC.
4001 NW 97TH AVE, SUITE 101
MIAMI, FL 33178 US
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Contact JEFFERY RAINES
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Regulation Number 870.2780

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Classification Product Code JOM
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Date Received 09/25/1997
Decision Date 12/17/1997
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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