Cleared Traditional

Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors

K191018 · Surgical Instrument Service and Savings, Inc. · Anesthesiology
Jul 2019
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K191018 is an FDA 510(k) clearance for the Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors, a Oximeter, Reprocessed (Class II — Special Controls, product code NLF), submitted by Surgical Instrument Service and Savings, Inc. (Redmond, US). The FDA issued a Cleared decision on July 3, 2019, 77 days after receiving the submission on April 17, 2019. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K191018 FDA.gov
FDA Decision Cleared SESE
Date Received April 17, 2019
Decision Date July 03, 2019
Days to Decision 77 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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