Home / 510(k) Clearances / K090285

510(k) K090285

SONICAID FM820 AND FM830 ENCORE by Huntleigh Healthcare , Ltd. — Product Code HGM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 2009
Date Received
February 5, 2009
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 Huntleigh Healthcare , Ltd.

  • K250777 — Sonicaid Team3 (September 19, 2025)
  • K241368 — Sonicaid Team3 (February 3, 2025)
  • K211200 — WoundExpress (September 3, 2021)
  • K183574 — SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes (September 6, 2019)
  • K152228 — Hydroven 12, Hydroven 12 Garments (April 4, 2016)
  • K121108 — DOPPLEX ABILITY (January 3, 2013)
  • K081572 — SMARTSIGNS MINPULSE (October 1, 2008)
  • K060230 — DOPPLEX CENTRALE (March 23, 2006)
  • K053369 — MEDILOG DARWIN HOLTER ANALYSIS (December 22, 2005)
  • K032315 — IOP8 INTRA OPERATIVE PROBE (November 18, 2004)

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)