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510(k) K771379

FETAL MONITORING SYS. MODEL FM3R by Sonicaid, Inc. — Product Code HGM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1977
Date Received
July 26, 1977
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 Sonicaid, Inc.

  • K873673 — BV105 (&BV105R) VASCULAR FLOW DETECTOR W/OPTIONAL (February 26, 1988)
  • K872074 — 5 MHZ TRANSDUCER (August 25, 1987)
  • K863803 — VASOPULSE(TM)/MODEL 5000 (May 6, 1987)
  • K862720 — VASOFLO-3 & EXTRAVASCULAR BLOOD FLOW PROBES (November 17, 1986)
  • K861237 — VASOVIEW DUPLEX IMAGING SYSTEM (July 14, 1986)
  • K851102 — VASOSCREEN IMPEDANCE PLETHYSMOGRAPH (May 16, 1985)
  • K833902 — VASOSCAN (January 27, 1984)
  • K832374 — PHOTOFLO DUAL-MODE PHOTOPLETHYSMOGRAPH (December 1, 1983)
  • K833488 — SONICOMP (November 28, 1983)
  • K833227 — SONICAID MODEL D206E AIR EMBOLI-DETECT (October 27, 1983)

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)