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510(k) K110556

MINI TELEMETRY SYSTEM by Wipro GE Healthcare Private, Ltd. — Product Code HGM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 2011
Date Received
February 28, 2011
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 Wipro GE Healthcare Private, Ltd.

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  • K121625 — LULLABY TM WARMER (September 14, 2012)
  • K120168 — LULLABY LED PHOTTHERAPY SYSTEM (May 2, 2012)
  • K102104 — GE VIVID P3 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM (October 1, 2010)

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)