Cleared Special

Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor

K201699 · Surgical Instrument and Savings Inc (Dba Medline Renewal) · Anesthesiology
Jul 2020
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K201699 is an FDA 510(k) clearance for the Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor, a Oximeter, Reprocessed (Class II — Special Controls, product code NLF), submitted by Surgical Instrument and Savings Inc (Dba Medline Renewal) (Redmond, US). The FDA issued a Cleared decision on July 22, 2020, 30 days after receiving the submission on June 22, 2020. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K201699 FDA.gov
FDA Decision Cleared SESE
Date Received June 22, 2020
Decision Date July 22, 2020
Days to Decision 30 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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