510(k) K181089
K181089 is an FDA 510(k) premarket notification submitted by Authentic Medical for the device "SureLead Cable System". The FDA issued a decision of Substantially Equivalent on Jan 17, 2020. The device falls under product code DSA (Cable, Transducer And Electrode, Patient, (Including Connector)), a Class II device regulated under 21 CFR 870.2900.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 17, 2020
- Date Received
- Apr 25, 2018
- 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
- 510(k)