510(k) K242986

SpO2 Extension Cable by Beijing Rongrui-Century Science & Technology Co., Ltd. — Product Code DSA

K242986 is an FDA 510(k) premarket notification submitted by Beijing Rongrui-Century Science & Technology Co., Ltd. for the device "SpO2 Extension Cable". The FDA issued a decision of Substantially Equivalent on May 2, 2025. The device falls under product code DSA (Cable, Transducer And Electrode, Patient, (Including Connector)), a Class II device regulated under 21 CFR 870.2900. Beijing Rongrui-Century Science & Technology Co., Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2025
Date Received
September 26, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cable, Transducer And Electrode, Patient, (Including Connector)
Device Class
Class II
Regulation Number
870.2900
Review Panel
CV
Submission Type