510(k) K201168
K201168 is an FDA 510(k) premarket notification submitted by Samsung Electronics Co., Ltd. for the device "ECG Monitor App". The FDA issued a decision of Substantially Equivalent on August 4, 2020. The device falls under product code QDA (Electrocardiograph Software For Over-The-Counter Use), a Class II device regulated under 21 CFR 870.2345. Samsung Electronics Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 4, 2020
- Date Received
- May 1, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrocardiograph Software For Over-The-Counter Use
- Device Class
- Class II
- Regulation Number
- 870.2345
- Review Panel
- CV
- Submission Type
An electrocardiograph software device for over-the-counter use creates, analyzes, and displays electrocardiograph data, and can provide information for identifying cardiac arrhythmias. This device is not intended to provide a diagnosis.