The following data is part of a premarket notification filed by Samsung Electronics Co., Ltd with the FDA for Ecg Monitor App.
| Device ID | K201168 |
| 510k Number | K201168 |
| Device Name: | ECG Monitor App |
| Classification | Electrocardiograph Software For Over-the-counter Use |
| Applicant | Samsung Electronics Co., Ltd 129, Samsung-ro, Yeongtong-gu, Suwon-si, KR 16677 |
| Contact | Taejong Jay Yang |
| Correspondent | Matthew Wiggins Samsung Electronics Co., Ltd 665 Clyde Avenue Mountain View, CA 94043 |
| Product Code | QDA |
| CFR Regulation Number | 870.2345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-01 |
| Decision Date | 2020-08-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806090792045 | K201168 | 000 |
| 08806090792021 | K201168 | 000 |