FDA 510(k) Application Details - K073398

Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive

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510(K) Number K073398
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant MICROLIFE CORP.
55 Northern Blvd.
Suite 200
Great Neck, NY 11021 US
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Contact SUSAN D GOLDSTEIN-FALK
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 12/03/2007
Decision Date 12/20/2007
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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