510(k) K242986
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