510(k) K243566
K243566 is an FDA 510(k) premarket notification submitted by Cardiosense, Inc. for the device "CardioTag". The FDA issued a decision of Substantially Equivalent on Jul 22, 2025. The device falls under product code DXR (Ballistocardiograph), a Class II device regulated under 21 CFR 870.2320. Cardiosense, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 22, 2025
- Date Received
- Nov 18, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ballistocardiograph
- Device Class
- Class II
- Regulation Number
- 870.2320
- Review Panel
- CV
- Submission Type