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FDA 510(k) Application Details - K070500
Device Classification Name
Plethysmograph, Impedance
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510(K) Number
K070500
Device Name
Plethysmograph, Impedance
Applicant
NI MEDICAL
414 MARYJOE WAY
WARRINGTON, PA 18976 US
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Contact
JAMES COLLIE
Other 510(k) Applications for this Contact
Regulation Number
870.2770
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Classification Product Code
DSB
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More FDA Info for this Product Code
Date Received
02/21/2007
Decision Date
07/16/2007
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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