Cleared Traditional

Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103, UC-104)

K222213 · Unimed Medical Supplies, Inc. · Anesthesiology
Dec 2022
Decision
147d
Days
Class 2
Risk

About This 510(k) Submission

K222213 is an FDA 510(k) clearance for the Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103, UC-104), a Oximeter (Class II — Special Controls, product code DQA), submitted by Unimed Medical Supplies, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on December 19, 2022, 147 days after receiving the submission on July 25, 2022. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K222213 FDA.gov
FDA Decision Cleared SESE
Date Received July 25, 2022
Decision Date December 19, 2022
Days to Decision 147 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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