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
K993608Substantially Equivalent

Datex-Ohmeda Ne12stpr Module (Model Family M-Ne12stpr)

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

K993608 is the FDA 510(k) clearance record for DATEX-OHMEDA NE12STPR MODULE (MODEL FAMILY M-NE12STPR), a class II device, cleared for Datex-Ohmeda, Inc. on under FDA product code MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)). FDA records list 888 510(k) clearances for GE HEALTHCARE, from to . As of , FDA records show no recalls naming K993608.

Clearance record

Decision date
Received
(171 days to decision)
Product code
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
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 MHX

Trailing 12 months
15 clearances under product code MHX in the twelve months to November 2026, April 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code MHX, trailing twelve months
MonthClearances
December 20251
January 20261
February 20261
March 20260
April 20263
May 20262
June 20261
July 20261
August 20263
September 20261
October 20261
November 20260