510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K920590Substantially Equivalent

Ohmeda Model 5250 Rgm Monitor

GE Healthcare, Louisville CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K920590 is the FDA 510(k) clearance record for OHMEDA MODEL 5250 RGM MONITOR, a class II device, cleared for Ohmeda Medical on under FDA product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase). FDA records list 888 510(k) clearances for GE HEALTHCARE, from to . As of , FDA records show no recalls naming K920590.

Clearance record

Decision date
Received
(203 days to decision)
Product code
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Regulation
21 CFR 868.1400
Device class
Class II
Review panel
Anesthesiology
Applicant
Ohmeda Medical 1315 W. Louisville Dr., Louisville CO
510(k) summary
Statement
Third party review
No

Clearances, product code CCK

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