Cleared Traditional

DATEX-OHMEDA OXY-AFR SENSOR

K042891 · Datex-Ohmeda · Anesthesiology
Jun 2005
Decision
253d
Days
Class 2
Risk

About This 510(k) Submission

K042891 is an FDA 510(k) clearance for the DATEX-OHMEDA OXY-AFR SENSOR, a Oximeter, Reprocessed (Class II — Special Controls, product code NLF), submitted by Datex-Ohmeda (Needham, US). The FDA issued a Cleared decision on June 29, 2005, 253 days after receiving the submission on October 19, 2004. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K042891 FDA.gov
FDA Decision Cleared SESE
Date Received October 19, 2004
Decision Date June 29, 2005
Days to Decision 253 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code NLF — Oximeter, Reprocessed
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2700
Definition Same As Dqa Except Reprocessed. Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. (70 Fr 56911, Available At Https://www.govinfo.gov/content/pkg/fr-2005-09-29/pdf/05-19510.pdf).

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