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510(k) K153135

VITAL SIGNS MONITOR by Guangdong Biolight Meditech Co., Ltd. — Product Code MWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 2016
Date Received
October 30, 2015
Clearance Type
Special
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)
  • 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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