Cleared Traditional

Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001), Reprocessed RD SET Inf Pulse Oximeter Sensor (4002), Reprocessed RD SET Adt Pulse Oximeter Sensor (4003)

K222019 · Stryker Sustainability Solutions · Anesthesiology
Dec 2022
Decision
149d
Days
Class 2
Risk

About This 510(k) Submission

K222019 is an FDA 510(k) clearance for the Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001), Reprocessed RD SET Inf Pulse Oximeter Sensor (4002), Reprocessed RD SET Adt Pulse Oximeter Sensor (4003), a Oximeter, Reprocessed (Class II — Special Controls, product code NLF), submitted by Stryker Sustainability Solutions (Tempe, US). The FDA issued a Cleared decision on December 4, 2022, 149 days after receiving the submission on July 8, 2022. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K222019 FDA.gov
FDA Decision Cleared SESE
Date Received July 08, 2022
Decision Date December 04, 2022
Days to Decision 149 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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