Cleared Traditional

Pulse Oximeter

K212300 · Shenzhen Mericonn Technology Co., Ltd. · Anesthesiology
Feb 2022
Decision
218d
Days
Class 2
Risk

About This 510(k) Submission

K212300 is an FDA 510(k) clearance for the Pulse Oximeter, a Oximeter (Class II — Special Controls, product code DQA), submitted by Shenzhen Mericonn Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on February 25, 2022, 218 days after receiving the submission on July 22, 2021. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K212300 FDA.gov
FDA Decision Cleared SESE
Date Received July 22, 2021
Decision Date February 25, 2022
Days to Decision 218 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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