Cleared Traditional

APK SPO2 PULSE OXIMETER SENSOR

K082846 · APK Technology Co., Ltd. · Anesthesiology
Apr 2009
Decision
186d
Days
Class 2
Risk

About This 510(k) Submission

K082846 is an FDA 510(k) clearance for the APK SPO2 PULSE OXIMETER SENSOR, a Oximeter (Class II — Special Controls, product code DQA), submitted by APK Technology Co., Ltd. (No. 2 Road(S); Shanghai, CN). The FDA issued a Cleared decision on April 3, 2009, 186 days after receiving the submission on September 29, 2008. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K082846 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2008
Decision Date April 03, 2009
Days to Decision 186 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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