FDA 510(k), K113657, INTELLIVUE PATIENT MONITOR

FDA 510(k), K113657, INTELLIVUE PATIENT MONITOR

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510(K) Number: K113657
Device Name: INTELLIVUE PATIENT MONITOR
Manufacturer: PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH
Device Classification Name: monitor, physiological, patient(with arrhythmia detection or alarms)
Regulation Number: 870.1025
Classification Product Code: MHX
Date Received: 12/12/2011
Decision Date: 03/22/2012
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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