ECG Check - Universal, ECG Check - Universal Plus— 510(k) K170506
Substantially EquivalentCardiac Designs, Inc.
FDA 510(k) clearance K170506 for ECG Check - Universal, ECG Check - Universal Plus, Substantially Equivalent on 2017-10-02. Applicant: Cardiac Designs, Inc.. Device class: 2.
Clearance details
- Applicant
- Cardiac Designs, 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
- Spring, TX, US
Recent devices under product code DXH
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