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510(k) K800013

FETAL MONITOR MODEL FHM-1 by Advantage Medical Systems, Inc. — Product Code HGM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 1980
Date Received
January 4, 1980
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 Advantage Medical Systems, Inc.

  • K873957 — NON-CORING HUBER TYPE NEEDLES (October 23, 1987)
  • K873290 — LACERATION AND INSTRUMENT TRAYS (September 24, 1987)
  • K863494 — NEONATAL PHYSIOLOGICAL MONITOR MODEL PM 20 (December 22, 1986)
  • K861556 — MODIFIED FETAL MONITOR MODEL FM-2 (July 7, 1986)
  • K861279 — FLUORO PLUS (June 16, 1986)
  • K861455 — MODEL DT-102 DATA TELEPHONE TRANSMITTER (May 30, 1986)
  • K852518 — MODIFICATION FETAL MONITOR MODEL FM-2 (July 5, 1985)
  • K844724 — FETAL TELEMETRY SYSTEM (May 1, 1985)
  • K842462 — HOLTER SCREENING MONITOR HS-221 (September 11, 1984)
  • K840747 — TOCO DATA TELEPHONE TRANSMITTER DT100P (June 19, 1984)

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)