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FDA 510(k) Application Details - K080670
Device Classification Name
Computer, Blood-Pressure
More FDA Info for this Device
510(K) Number
K080670
Device Name
Computer, Blood-Pressure
Applicant
ATCOR MEDICAL
11/1059-1063 VICTORIA
ROAD
WEST RYDE NSW 2114 AU
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Contact
JOHN ABRAM
Other 510(k) Applications for this Contact
Regulation Number
870.1110
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Classification Product Code
DSK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/10/2008
Decision Date
04/23/2008
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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