The following data is part of a premarket notification filed by Atsens Co., Ltd with the FDA for At-patch Ecg Analysis System.
| Device ID | K203638 |
| 510k Number | K203638 |
| Device Name: | AT-Patch ECG Analysis System |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | ATsens Co., Ltd Point Town 806, 11, Gumi-ro, Bundang-gu Seongnam-si, KR 13637 |
| Contact | KeonHoon Lee |
| Correspondent | Do Hyun Kim BT Solutions, Inc. Unit 904, Eonju-ro 86-gil 5, Gangnam-gu Seoul, KR 06210 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-14 |
| Decision Date | 2022-10-12 |