Cleared Traditional

RENU MEDICAL OXIMETRY SENSOR, ADULT, PED, INF,NEO

K081927 · Renu Medical, Inc. · Anesthesiology
Feb 2009
Decision
214d
Days
Class 2
Risk

About This 510(k) Submission

K081927 is an FDA 510(k) clearance for the RENU MEDICAL OXIMETRY SENSOR, ADULT, PED, INF,NEO, a Oximeter, Reprocessed (Class II — Special Controls, product code NLF), submitted by Renu Medical, Inc. (Everett, US). The FDA issued a Cleared decision on February 6, 2009, 214 days after receiving the submission on July 7, 2008. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K081927 FDA.gov
FDA Decision Cleared SESE
Date Received July 07, 2008
Decision Date February 06, 2009
Days to Decision 214 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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