FDA 510(k) Application Details - K080670

Device Classification Name Computer, Blood-Pressure

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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
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Regulation Number 870.1110

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Classification Product Code DSK
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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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