The following data is part of a premarket notification filed by Sound Land Corp. with the FDA for Ibiomedi Electronic Stethoscope Es-2020.
| Device ID | K220466 |
| 510k Number | K220466 |
| Device Name: | Ibiomedi Electronic Stethoscope ES-2020 |
| Classification | Stethoscope, Electronic |
| Applicant | Sound Land Corp. No.32, Keji 1st Rd., Guishan Dist. Taoyuan, TW 33383 |
| Contact | Chi-Hsun Hung |
| Correspondent | Chi-Hsun Hung Sound Land Corp. No.32, Keji 1st Rd., Guishan Dist. Taoyuan, TW 33383 |
| Product Code | DQD |
| CFR Regulation Number | 870.1875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-17 |
| Decision Date | 2022-11-03 |