ECG CHECK— 510(k) K122184
Substantially EquivalentCardiac Designs, LLC
FDA 510(k) clearance K122184 for ECG CHECK, Substantially Equivalent on 2013-02-14. Applicant: Cardiac Designs, LLC. Device class: 2.
Clearance details
- Applicant
- Cardiac Designs, LLC
- 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
- Park City, UT, US
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