The following data is part of a premarket notification filed by Sigknow Biomedical Co.,ltd. with the FDA for Ezypro Ecg Recorder (model: Ug02).
| Device ID | K213233 |
| 510k Number | K213233 |
| Device Name: | EZYPRO ECG Recorder (Model: UG02) |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | Sigknow Biomedical Co.,Ltd. 6F., No. 760, Sec. 4, Bade Rd., Songshan Dist, Taipei City, TW 105412 |
| Contact | Hsiao-Fan Liu |
| Correspondent | Hsiao-Fan Liu Sigknow Biomedical Co.,Ltd. 6F., No. 760, Sec. 4, Bade Rd., Songshan Dist, Taipei City, TW 105412 |
| Product Code | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-30 |
| Decision Date | 2022-06-23 |