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510(k) K002150

SONICAID FM820, SONICAID FM830 by Oxford Instruments — Product Code HGM

K002150 is an FDA 510(k) premarket notification submitted by Oxford Instruments for the device "SONICAID FM820, SONICAID FM830". The FDA issued a decision of Substantially Equivalent on March 9, 2001. The device falls under product code HGM (System, Monitoring, Perinatal), a Class II device regulated under 21 CFR 884.2740. Oxford Instruments has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 2001
Date Received
July 17, 2000
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 Oxford Instruments

  • K002544 — MEDILOG EXCEL 2 - HOLTER MANAGEMENT SYSTEM (September 13, 2000)
  • K981405 — SYNERGY LT (July 16, 1998)
  • K961642 — MEDILOG MR95 (January 17, 1997)
  • K961636 — MEDILOG VISION (January 17, 1997)
  • K930714 — SONICAID MODEL TEAM FECG IUP (August 24, 1995)
  • K933816 — SONICAID MODEL P110 FETAL HEAR DETECTOR (December 22, 1994)

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)

FDA data resources