Cleared Traditional

OHMEDA 3800 PULSE OXIMETER

K962127 · Ohmeda Medical · Anesthesiology
Oct 1996
Decision
129d
Days
Class 2
Risk

About This 510(k) Submission

K962127 is an FDA 510(k) clearance for the OHMEDA 3800 PULSE OXIMETER, a Oximeter (Class II — Special Controls, product code DQA), submitted by Ohmeda Medical (Madison, US). The FDA issued a Cleared decision on October 10, 1996, 129 days after receiving the submission on June 3, 1996. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K962127 FDA.gov
FDA Decision Cleared SESE
Date Received June 03, 1996
Decision Date October 10, 1996
Days to Decision 129 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code DQA — Oximeter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2700

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