Cleared Traditional

Reusable SpO2 Sensors, Disposable SpO2 Sensors

K172981 · APK Technology Co., Ltd. · Anesthesiology
Jun 2018
Decision
254d
Days
Class 2
Risk

About This 510(k) Submission

K172981 is an FDA 510(k) clearance for the Reusable SpO2 Sensors, Disposable SpO2 Sensors, a Oximeter (Class II — Special Controls, product code DQA), submitted by APK Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on June 8, 2018, 254 days after receiving the submission on September 27, 2017. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K172981 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 2017
Decision Date June 08, 2018
Days to Decision 254 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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