FDA 510(k), K132662, PASSPORT SERIES PATIENT MONITORS

FDA 510(k), K132662, PASSPORT SERIES PATIENT MONITORS

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510(K) Number: K132662
Device Name: PASSPORT SERIES PATIENT MONITORS
Manufacturer: SHENZHEN MINDRAY BIOMEDICAL ELECTRONICS CO. LTD
Device Classification Name: monitor, physiological, patient(with arrhythmia detection or alarms)
Regulation Number: 870.1025
Classification Product Code: MHX
Date Received: 08/26/2013
Decision Date: 08/01/2014
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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