Cleared Traditional

Medke Oximetry Finger Sensor

K152390 · Shenzhen Medke Technology Co., Ltd. · Anesthesiology
Aug 2016
Decision
360d
Days
Class 2
Risk

About This 510(k) Submission

K152390 is an FDA 510(k) clearance for the Medke Oximetry Finger Sensor, a Oximeter (Class II — Special Controls, product code DQA), submitted by Shenzhen Medke Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on August 18, 2016, 360 days after receiving the submission on August 24, 2015. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K152390 FDA.gov
FDA Decision Cleared SESE
Date Received August 24, 2015
Decision Date August 18, 2016
Days to Decision 360 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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