CardioTag— 510(k) K243566
Substantially EquivalentCardiosense, Inc.
FDA 510(k) clearance K243566 for CardioTag, Substantially Equivalent on 2025-07-22. Applicant: Cardiosense, Inc.. Device class: 2.
Clearance details
- Applicant
- Cardiosense, Inc.
- Product code
- Code DXR
- Device class
- Class 2
- Regulation
- 21 CFR 870.2320
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chicago, IL, US
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