510(k) K203556
K203556 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient Cables". The FDA issued a decision of Substantially Equivalent on July 12, 2021. The device falls under product code DSA (Cable, Transducer And Electrode, Patient, (Including Connector)), a Class II device regulated under 21 CFR 870.2900. Medtronic, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 12, 2021
- Date Received
- December 7, 2020
- 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