FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Samsung ECG App v 1.3 (ECG)
K Number: K240909
·
Decision Aug 2, 2024
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
8
Applicant Total
40
Review Days
122
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Basic Information
- Device Name
- Samsung ECG App v 1.3 (ECG)
- K Number
- K240909
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2345
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Samsung Electronics Co., Ltd.
- Date Received
- April 2, 2024
- Decision Date
- August 2, 2024
- Product Code
- QDA
- 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 |
|---|---|---|---|
| QDA | Electrocardiograph Software For Over-The-Counter Use | FDA class 2 | Cardiovascular |
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Other Clearances by Samsung Electronics Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K242651 | GM85 | Oct 1, 2024 | Substantially Equivalent |
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| DEN230041 | Sleep Apnea Feature | Feb 6, 2024 | Unknown |
| K230292 | Samsung ECG Monitor Application with Irregular Heart Rhythm Notification | May 2, 2023 | Substantially Equivalent |
| K222353 | GM85 | Sep 29, 2022 | Substantially Equivalent |
| K213452 | GEMS-H | Apr 21, 2022 | Substantially Equivalent |
| K220175 | GM85 | Apr 21, 2022 | Substantially Equivalent |
| K211139 | CUBE Air Purifier | Nov 26, 2021 | Substantially Equivalent |
| K201560 | Auto Lung Nodule Detection | Aug 31, 2021 | Substantially Equivalent |
| K201168 | ECG Monitor App | Aug 4, 2020 | Substantially Equivalent |