510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K962127Substantially Equivalent

Ohmeda 3800 Pulse Oximeter

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

K962127 is the FDA 510(k) clearance record for OHMEDA 3800 PULSE OXIMETER, a class II device, cleared for Ohmeda Medical on under FDA product code DQA (Oximeter). FDA records list 888 510(k) clearances for GE HEALTHCARE, from to . As of , FDA records show no recalls naming K962127.

Clearance record

Decision date
Received
(129 days to decision)
Product code
DQA Oximeter
Regulation
21 CFR 870.2700
Device class
Class II
Review panel
Cardiovascular
Applicant
Ohmeda Medical Ohmeda Dr., Madison WI
510(k) summary
Summary
Third party review
No

Clearances, product code DQA

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