510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K040831Substantially Equivalent

Datex-Ohmeda Trusat Pulse Oximeter and Accessories, Model 3500

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

K040831 is the FDA 510(k) clearance record for DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500, a class II device, cleared for Datex-Ohmeda, Inc. on under FDA product code DPZ (Oximeter, Ear). FDA records list 888 510(k) clearances for GE HEALTHCARE, from to . As of , FDA records show 5 recalls naming K040831.

Clearance record

Decision date
Received
(155 days to decision)
Product code
DPZ Oximeter, Ear
Regulation
21 CFR 870.2710
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 DPZ

Trailing 12 months

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

FDA records show no clearances under product code DPZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DPZ, 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