FDA 510(k), K110044, FORA P30 PLUS MULTI-MODE BLOOD PRESSURE MONITORING SYSTEM

FDA 510(k), K110044, FORA P30 PLUS MULTI-MODE BLOOD PRESSURE MONITORING SYSTEM

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510(K) Number: K110044
Device Name: FORA P30 PLUS MULTI-MODE BLOOD PRESSURE MONITORING SYSTEM
Manufacturer: TELING HSU
Device Classification Name: System, Measurement, Blood-Pressure, Non-Invasive
Regulation Number: DXN
Classification Product Code: KXA
Date Received: 01/06/2011
Decision Date: 07/07/2011
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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