510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K050583Substantially Equivalent

Model 250 Series Maternal/fetal Monitor

GE Medical Systems Information Technologies, Inc., Tampa FL / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K050583 is the FDA 510(k) clearance record for MODEL 250 SERIES MATERNAL/FETAL MONITOR, a class II device, cleared for Ge Medical Systems Information Technologies on under FDA product code HGM (System, Monitoring, Perinatal). FDA records list 171 510(k) clearances for Ge Medical Systems Information Technologies, from to . As of , FDA records show no recalls naming K050583.

Clearance record

Decision date
Received
(106 days to decision)
Product code
HGM System, Monitoring, Perinatal
Regulation
21 CFR 884.2740
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Ge Medical Systems Information Technologies 4502 Woodland Corporate Blvd., Tampa FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HGM

Trailing 12 months
2 clearances under product code HGM in the twelve months to November 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HGM, trailing twelve months
MonthClearances
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260
November 20260