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510(k) K112803

PATIENT MONITOR by Guangdong Biolight Meditech Co., Ltd. — Product Code MHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2011
Date Received
September 27, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type

Other clearances by Guangdong Biolight Meditech Co., Ltd.

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  • 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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