Cleared Special

Pulse Oximeter (Model C101A2, C101B1, C101A3)

K221979 · Shenzhen Imdk Medical Technology Co., Ltd. · Anesthesiology
Oct 2022
Decision
103d
Days
Class 2
Risk

About This 510(k) Submission

K221979 is an FDA 510(k) clearance for the Pulse Oximeter (Model C101A2, C101B1, C101A3), a Oximeter (Class II — Special Controls, product code DQA), submitted by Shenzhen Imdk Medical Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 16, 2022, 103 days after receiving the submission on July 5, 2022. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K221979 FDA.gov
FDA Decision Cleared SESE
Date Received July 05, 2022
Decision Date October 16, 2022
Days to Decision 103 days
Submission Type Special
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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