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510(k) K871082

FETAL CARE MONITOR ANTEPARTUM 1500 by Pie Data Medical BV — Product Code HGM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 1987
Date Received
March 18, 1987
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 Pie Data Medical BV

  • K874192 — MULTIPURPOSE TRANSDUCER RANGE (July 19, 1988)
  • K870058 — PIE MEDICAL SCANNER 1000 (February 2, 1988)
  • K870653 — ULTRASOUND LINEAR/SECTOR SCANNER 1100 (February 2, 1988)
  • K874081 — ENTERSCAN (December 31, 1987)

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)