COROMETRICS MODEL 150 FETAL MONITOR— 510(k) K920376

Name: FDA 510(k) clearance K920376
Creator: U.S. Food and Drug Administration
Published: 1992-04-27

Substantially Equivalent

Ge Medical Systems Information Technologies

FDA 510(k) clearance K920376 for COROMETRICS MODEL 150 FETAL MONITOR, Substantially Equivalent on 1992-04-27. Applicant: Ge Medical Systems Information Technologies. Device class: 2.

Clearance details

Applicant: Ge Medical Systems Information Technologies
Product code: Code HGM
Device class: Class 2
Regulation: 21 CFR 884.2740
Advisory panel: Obstetrics/Gynecology
Date received: 1992-01-29
Decision date: 1992-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wallingford, CT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HGM

view all

K254036 — Novii+ Wireless Patch System2026-08-10
K253021 — ANNE Maternal2026-02-26
K250777 — Sonicaid Team32025-09-19
K241882 — Fetal & Maternal Monitor (F15A, F15A Air)2025-08-27
K241368 — Sonicaid Team32025-02-03

More clearances from Ge Medical Systems Information Technologies

view all

K120770 — QT GUARD PLUS ANALYSIS SYSTEM2012-12-06
K102426 — CARESCAPE MODEL V100 VITAL SIGNS MONITOR2010-10-20
K092369 — 12SL ECG ANALYSIS PROGRAM2010-02-24
K093141 — MARS HOLTER ANALYSIS WORKSTATION2009-12-29
K092027 — CARESCAPE MONITOR B8502009-08-28

Adverse events under product code HGM

product code HGM

Death: 35
Malfunction: 478
Total: 513

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.