Cleared Traditional

Med-link Pulse Oximeter

K212752 · Shenzhen Med-Link Electronics Tech Co., Ltd. · Anesthesiology
May 2022
Decision
263d
Days
Class 2
Risk

About This 510(k) Submission

K212752 is an FDA 510(k) clearance for the Med-link Pulse Oximeter, a Oximeter (Class II — Special Controls, product code DQA), submitted by Shenzhen Med-Link Electronics Tech Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on May 20, 2022, 263 days after receiving the submission on August 30, 2021. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K212752 FDA.gov
FDA Decision Cleared SESE
Date Received August 30, 2021
Decision Date May 20, 2022
Days to Decision 263 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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