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 | K191055 |
| 510k Number | K191055 |
| 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 | Scully Kim |
| Correspondent | Scully Kim 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 | 2019-04-19 |
| Decision Date | 2019-06-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809521021974 | K191055 | 000 |
| 08809521021776 | K191055 | 000 |
| 08809521021578 | K191055 | 000 |
| 08809521021219 | K191055 | 000 |
| 08809521021172 | K191055 | 000 |
| 08809521021165 | K191055 | 000 |
| 08809521020960 | K191055 | 000 |
| 08809521020762 | K191055 | 000 |