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510(k) K760919

MODEL 2106 FETA SONDE FETAL MONITOR by Roche Medical Electronics, Inc. — Product Code HGM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1976
Date Received
October 28, 1976
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 Roche Medical Electronics, Inc.

  • K791559 — ROCHE SENSOR ADAPTOR (November 21, 1979)
  • K791039 — FETASONDE FETAL HEART RATE VARIABILITY (September 4, 1979)
  • K791035 — FETASONDE FETAL ACTIVITY MONITOR (September 4, 1979)
  • K791036 — FETASONDE UTERINE WORK MONITOR (September 4, 1979)
  • K791037 — FETASONDE LABOR STATUS DISPLAY (September 4, 1979)
  • K791038 — FETASONDE UTERINE ACTIVITY MONITOR (September 4, 1979)
  • K790761 — FETASONDE MODEL 2108 (June 1, 1979)
  • K790421 — ROCHE LACTATE ANALYZER 640 (May 15, 1979)
  • K782089 — MONITOR, HEART RATE MODEL 103 (January 4, 1979)
  • K782088 — MONITOR, HEART RATE MODEL 105 (January 4, 1979)

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)