510(k) K240377
K240377 is an FDA 510(k) premarket notification submitted by Stryker Physio-Control for the device "LIFEPAK® ECG Cables". The FDA issued a decision of Substantially Equivalent on May 7, 2024. The device falls under product code DSA (Cable, Transducer And Electrode, Patient, (Including Connector)), a Class II device regulated under 21 CFR 870.2900. Stryker Physio-Control has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 7, 2024
- Date Received
- February 7, 2024
- 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