The following data is part of a premarket notification filed by Samsung Medison Co., Ltd. with the FDA for Hs50/hs60 Diagnostics Ultrasound System.
| Device ID | K192505 |
| 510k Number | K192505 |
| Device Name: | HS50/HS60 Diagnostics 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 | 2019-09-12 |
| Decision Date | 2019-12-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809521028805 | K192505 | 000 |
| 08806167798604 | K192505 | 000 |
| 08806167799014 | K192505 | 000 |
| 08809702980748 | K192505 | 000 |
| 08809702986481 | K192505 | 000 |
| 08809702986566 | K192505 | 000 |
| 08809702986580 | K192505 | 000 |
| 08809521026719 | K192505 | 000 |
| 08809521026900 | K192505 | 000 |
| 08809521027099 | K192505 | 000 |
| 08809521027280 | K192505 | 000 |
| 08809521027471 | K192505 | 000 |
| 08809521027662 | K192505 | 000 |
| 08809521027853 | K192505 | 000 |
| 08809521028041 | K192505 | 000 |
| 08809521028232 | K192505 | 000 |
| 08809521028423 | K192505 | 000 |
| 08809521028614 | K192505 | 000 |
| 08806167793388 | K192505 | 000 |