510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K850494Substantially Equivalent

Ohmeda Biox 3700 Pulse Oximeter

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

K850494 is the FDA 510(k) clearance record for OHMEDA BIOX 3700 PULSE OXIMETER, a class II device, cleared for Ohmeda Medical 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 no recalls naming K850494.

Clearance record

Decision date
Received
(48 days to decision)
Product code
DPZ Oximeter, Ear
Regulation
21 CFR 870.2710
Device class
Class II
Review panel
Cardiovascular
Applicant
Ohmeda Medical Ohmeda Dr., Madison WI
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