Cleared Special

SpO2 Extension Cable

K242986 · Beijing Rongrui-Century Science & Technology Co., Ltd. · Anesthesiology
May 2025
Decision
218d
Days
Class 2
Risk

About This 510(k) Submission

K242986 is an FDA 510(k) clearance for the SpO2 Extension Cable, a Cable, Transducer And Electrode, Patient, (including Connector) (Class II — Special Controls, product code DSA), submitted by Beijing Rongrui-Century Science & Technology Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on May 2, 2025, 218 days after receiving the submission on September 26, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2900.

Submission Details

510(k) Number K242986 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 2024
Decision Date May 02, 2025
Days to Decision 218 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code DSA — Cable, Transducer And Electrode, Patient, (including Connector)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2900

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