510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K021955Substantially Equivalent

Trutrak Plus Enhancements to the Datex-Ohmeda 3800 Series & 3900 Series Oximeters & Accessories

GE Healthcare, Louisville CO / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K021955 is the FDA 510(k) clearance record for TRUTRAK PLUS ENHANCEMENTS TO THE DATEX-OHMEDA 3800 SERIES & 3900 SERIES OXIMETERS & ACCESSORIES, a class II device, cleared for Datex-Ohmeda, Inc. on under FDA product code DQA (Oximeter). FDA records list 888 510(k) clearances for GE HEALTHCARE, from to . As of , FDA records show 2 recalls naming K021955.

Clearance record

Decision date
Received
(116 days to decision)
Product code
DQA Oximeter
Regulation
21 CFR 870.2700
Device class
Class II
Review panel
Cardiovascular
Applicant
Datex-Ohmeda, Inc. 1315 W. Century Dr., Louisville CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DQA

Trailing 12 months
12 clearances under product code DQA in the twelve months to October 2026, December 2025 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code DQA, trailing twelve months
MonthClearances
November 20252
December 20253
January 20261
February 20262
March 20260
April 20261
May 20263
June 20260
July 20260
August 20260
September 20260
October 20260