FDA 510(k), K173510, BioStamp nPoint

FDA 510(k), K173510, BioStamp nPoint

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510(K) Number: K173510
Device Name: BioStamp nPoint
Manufacturer: MC10 Inc.
Device Classification Name: transmitters and receivers, physiological signal, radiofrequency
Regulation Number: 870.2910
Classification Product Code: DRG
Date Received: 11/13/2017
Decision Date: 05/08/2018
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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