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510(k) K131898

A SERIES AND Q SERIES PATIENT MONITORS by Guangdong Biolight Meditech Co., Ltd. — Product Code MWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 2014
Date Received
June 25, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type

Other clearances by Guangdong Biolight Meditech Co., Ltd.

  • K181919 — Patient Monitor (April 5, 2019)
  • K170514 — Central Monitoring System (May 24, 2017)
  • K162234 — Truscope Ultra Patient Monitor (January 4, 2017)
  • K160349 — Electronic Sphygmomanometer (November 3, 2016)
  • K153580 — Central Monitoring System (September 7, 2016)
  • K153135 — VITAL SIGNS MONITOR (February 25, 2016)
  • K152739 — Electronic Thermometer (February 9, 2016)
  • K151287 — Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D (January 6, 2016)
  • K131858 — DIGITAL ELECTROCARDIOGRAPH (June 11, 2014)
  • K131762 — HANDHELD MONITOR (June 6, 2014)

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