FDA 510(k) Application Details - K061279

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

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510(K) Number K061279
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant LITTLE DOCTOR (SHANGHAI) ELECTRONIC
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 05/08/2006
Decision Date 08/18/2006
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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