SpO2 Extension Cable

FDA 510(k) clearance K242986 · decided 2025-05-02

Clearance details

K-number: K242986
Device name: SpO2 Extension Cable
Applicant: Beijing Rongrui-Century Science & Technology Co., Ltd.
Decision: Substantially Equivalent
Date received: 2024-09-26
Decision date: 2025-05-02
Days to decision: 218 days
Clearance type: Special
Product code: DSA
Device class: 2
Regulation number: 870.2900
Medical specialty: Cardiovascular
Advisory committee: Cardiovascular
Location: Beijing, CN
Third-party review: No
Expedited review: No

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Recalls involving this device

No recalls on record reference this clearance.