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510(k) K912890

MODEL SONICAID AXIS by Oxford Medilog, Inc. — Product Code HGM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 1992
Date Received
July 1, 1991
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 Medilog, Inc.

  • K923737 — MODEL MEDILOG RAPIDE (January 5, 1994)
  • K920295 — MEDILOG EXCEL ECG ANALYSIS SYSTEM (MODIFIED) (August 18, 1992)
  • K912639 — SONICAID TEAM (December 31, 1991)
  • K904763 — MENTOR EEG SYSTEM (April 10, 1991)
  • K902690 — SONICAID MODEL MERIDIAN 800 (February 5, 1991)
  • K895909 — SONICAID MODEL VASOFLO 4 (July 9, 1990)
  • K896535 — MEDILOG OPTIMA (January 18, 1990)
  • K891383 — MEDILOG 9200 EEG REPLAY/ANALYSIS SYSTEM (June 1, 1989)
  • K890330 — MEDILOG 6000-FD REPORT GENERATOR (April 20, 1989)
  • K890338 — MEDILOG EDITOR (April 19, 1989)

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)