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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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JEFFERY RAINES
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Regulation Number
870.2780
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Classification Product Code
JOM
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More FDA Info for this Product Code
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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