Cleared Traditional

RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE

K111773 · Renu Medical, Inc. · Anesthesiology
Nov 2011
Decision
146d
Days
Class 2
Risk

About This 510(k) Submission

K111773 is an FDA 510(k) clearance for the RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE, a Oximeter, Reprocessed (Class II — Special Controls, product code NLF), submitted by Renu Medical, Inc. (Everett, US). The FDA issued a Cleared decision on November 16, 2011, 146 days after receiving the submission on June 23, 2011. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K111773 FDA.gov
FDA Decision Cleared SESE
Date Received June 23, 2011
Decision Date November 16, 2011
Days to Decision 146 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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