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510(k) K990569

BABY DOPPLEX 4000, MODEL BD 4000 by Huntleigh Healthcare, Inc. — Product Code HGM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 2000
Date Received
February 23, 1999
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, Inc.

  • 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)
  • K090285 — SONICAID FM820 AND FM830 ENCORE (July 15, 2009)
  • K081572 — SMARTSIGNS MINPULSE (October 1, 2008)
  • K060230 — DOPPLEX CENTRALE (March 23, 2006)
  • K053369 — MEDILOG DARWIN HOLTER ANALYSIS (December 22, 2005)

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)