FDA 510(k), K101692, PATIENT MONITOR

FDA 510(k), K101692, PATIENT MONITOR

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510(K) Number: K101692
Device Name: PATIENT MONITOR
Manufacturer: CONTEC MEDICAL SYSTEM CO., LTD.
Device Classification Name: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Regulation Number: 870.1025
Classification Product Code: MHX
Date Received: 06/16/2010
Decision Date: 06/28/2011
Regulation Medical Specialty: Cardiovascular
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.

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