HeartBeam AIMIGo with 12-L ECG Synthesis Software System— 510(k) K250258
Substantially EquivalentHeartbeam, Inc.
FDA 510(k) clearance K250258 for HeartBeam AIMIGo with 12-L ECG Synthesis Software System, Substantially Equivalent on 2025-12-08. Applicant: Heartbeam, Inc.. Device class: 2.
Clearance details
- Applicant
- Heartbeam, Inc.
- Product code
- Code DXH
- Device class
- Class 2
- Regulation
- 21 CFR 870.2920
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Clara, CA, US
Recent devices under product code DXH
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