ECG SENTINEL System— 510(k) K172801
Substantially EquivalentCardiomedix, Inc.
FDA 510(k) clearance K172801 for ECG SENTINEL System, Substantially Equivalent on 2017-10-18. Applicant: Cardiomedix, Inc.. Device class: 2.
Clearance details
- Applicant
- Cardiomedix, 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
- Evanston, IL, US
Recent devices under product code DXH
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