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510(k) K131941

FETAL MONITORS by Guangdong Biolight Meditech Co., Ltd. — Product Code HGM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 2014
Date Received
June 27, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Monitoring, Perinatal
Device Class
Class II
Regulation Number
884.2740
Review Panel
OB
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)

Other clearances for product code HGM

  • K253021 — ANNE Maternal (February 26, 2026)
  • K250777 — Sonicaid Team3 (September 19, 2025)
  • K241882 — Fetal & Maternal Monitor (F15A, F15A Air) (August 27, 2025)
  • K241368 — Sonicaid Team3 (February 3, 2025)
  • K241009 — PeriCALM Patterns 3.0 (January 10, 2025)
  • K233440 — Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) (July 2, 2024)
  • K231964 — Novii+ Wireless Patch System (December 8, 2023)
  • K222327 — Bloomlife MFM-Pro (February 13, 2023)
  • K220732 — Mural Perinatal Surveillance (June 23, 2022)
  • K200975 — Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum (June 24, 2020)