Cleared Traditional

Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftNHC

K212555 · Covidien, LLC · Anesthesiology
May 2022
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K212555 is an FDA 510(k) clearance for the Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftNHC, a Oximeter (Class II — Special Controls, product code DQA), submitted by Covidien, LLC (Boulder, US). The FDA issued a Cleared decision on May 6, 2022, 266 days after receiving the submission on August 13, 2021. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K212555 FDA.gov
FDA Decision Cleared SESE
Date Received August 13, 2021
Decision Date May 06, 2022
Days to Decision 266 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code DQA — Oximeter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2700

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