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510(k) K160349

Electronic Sphygmomanometer by Guangdong Biolight Meditech Co., Ltd. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 2016
Date Received
February 8, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Device Class
Class II
Regulation Number
870.1130
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)
  • 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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