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FDA 510(k) Application Details - K030825
Device Classification Name
System, Measurement, Blood-Pressure, Non-Invasive
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510(K) Number
K030825
Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Applicant
AEROTEL MEDICAL SYSTEMS (1998) LTD.
377 ROUTE 17
HASBROUCK HEIGHTS, NJ 07604 US
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Contact
GEORGE MYERS
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Regulation Number
870.1130
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Classification Product Code
DXN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/14/2003
Decision Date
03/28/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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