FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
SmartCardia 7L Platform (MCT)
K Number: K240653
·
Decision Oct 31, 2024
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
20
Applicant Total
2
Review Days
238
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Basic Information
- Device Name
- SmartCardia 7L Platform (MCT)
- K Number
- K240653
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1025
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Smartcardia SA
- Date Received
- March 7, 2024
- Decision Date
- October 31, 2024
- Product Code
- QYX
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QYX | Outpatient Cardiac Telemetry | FDA class 2 | Cardiovascular |
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Other Clearances by Smartcardia SA
| K Number | Device Name | ||
|---|---|---|---|
| K231276 | SmartCardia 7L Platform | Aug 30, 2023 | Substantially Equivalent |