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510(k) K112187

FM-1000 PLUS FETAL MONITOR by Advanced Instrumentations, Inc. — Product Code HGM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 2011
Date Received
July 29, 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 Advanced Instrumentations, Inc.

  • K172931 — DUS-6000 Digital Ultrasonic Diagnostic Imaging System (December 1, 2017)
  • K172055 — DUS-7000 Digital Color Doppler Ultrasound System (August 31, 2017)
  • K141194 — FM-3000 FETAL MONITOR (November 19, 2014)
  • K132077 — PATIENT MONITOR (April 23, 2014)
  • K132059 — DIAGNOSTIC ULTRASOUND SYSTEM (October 25, 2013)
  • K123048 — PATIENT MONITOR MODELS PM-2000A, PM-2000A+, PM-2000A PRO (January 11, 2013)
  • K120075 — AM-6000 ANESTHESIA MACHINE (January 26, 2012)
  • K112317 — FM-9000 PLUS FETAL AND MATERNAL MONITOR (December 21, 2011)
  • K112529 — TD-5000 & TD-6000 ULTRASONIC TABLETOP DOPPLER (October 27, 2011)
  • K111934 — PD-100 SERIES ULTRASONIC POCKET DOPPLER (September 22, 2011)

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)