The following data is part of a premarket notification filed by Samsung Medison Co., Ltd. with the FDA for Hs40 Diagnostic Ultrasound System.
| Device ID | K210426 |
| 510k Number | K210426 |
| Device Name: | HS40 Diagnostic Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Samsung Medison CO., LTD. 3366, Hanseo-ro, Nam-myeon Hongcheon-gun, KR 25108 |
| Contact | Ju Jee Young |
| Correspondent | Jee Young Ju Samsung Medison CO., LTD. 3366, Hanseo-ro, Nam-myeon Hongcheon-gun, KR 25108 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-11 |
| Decision Date | 2021-05-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809725785962 | K210426 | 000 |
| 08809725787027 | K210426 | 000 |
| 08809725785740 | K210426 | 000 |
| 08809725785221 | K210426 | 000 |
| 08809725785023 | K210426 | 000 |
| 08809702988706 | K210426 | 000 |
| 08809702988676 | K210426 | 000 |