Cleared Special

M-LNCS OXIMETRY SENSORS, REPROCESSED M-LNCS OXIMETRY SENSORS

K110723 · Masimo Corporation · Anesthesiology
Jul 2011
Decision
134d
Days
Class 2
Risk

About This 510(k) Submission

K110723 is an FDA 510(k) clearance for the M-LNCS OXIMETRY SENSORS, REPROCESSED M-LNCS OXIMETRY SENSORS, a Oximeter, Reprocessed (Class II — Special Controls, product code NLF), submitted by Masimo Corporation (Irvine, US). The FDA issued a Cleared decision on July 28, 2011, 134 days after receiving the submission on March 16, 2011. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K110723 FDA.gov
FDA Decision Cleared SESE
Date Received March 16, 2011
Decision Date July 28, 2011
Days to Decision 134 days
Submission Type Special
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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