510(k) K220447
K220447 is an FDA 510(k) premarket notification submitted by Shenzhen Med-Link Electronics Tech Co., Ltd. for the device "Med-link Disposable ECG Cable and Leadwires". The FDA issued a decision of Substantially Equivalent on June 28, 2022. The device falls under product code DSA (Cable, Transducer And Electrode, Patient, (Including Connector)), a Class II device regulated under 21 CFR 870.2900. Shenzhen Med-Link Electronics Tech Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 28, 2022
- Date Received
- February 16, 2022
- Clearance Type
- Traditional
- 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