510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K992323Substantially Equivalent

Datex-Ohmeda Cardiocap 5, F-Mx, F-Mxg and Accessories

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

K992323 is the FDA 510(k) clearance record for DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES, a class II device, cleared for Datex-Ohmeda, Inc. on under FDA product code MLD (Monitor, St Segment With Alarm). FDA records list 888 510(k) clearances for GE HEALTHCARE, from to . As of , FDA records show one recall naming K992323.

Clearance record

Decision date
Received
(112 days to decision)
Product code
MLD Monitor, St Segment With Alarm
Regulation
21 CFR 870.1025
Device class
Class II
Review panel
Cardiovascular
Applicant
Datex-Ohmeda, Inc. 3 Highwood Dr., Tewksburt MA
510(k) summary
Statement
Third party review
No

Clearances, product code MLD

Trailing 12 months

FDA records hold no clearances under product code MLD in the trailing twelve months.

FDA records show no clearances under product code MLD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MLD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260