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510(k) K181919

Patient Monitor by Guangdong Biolight Meditech Co., Ltd. — Product Code MWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 2019
Date Received
July 18, 2018
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.

  • 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)
  • K131941 — FETAL MONITORS (May 15, 2014)

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