The following data is part of a premarket notification filed by Samsung Medison Co., Ltd. with the FDA for Hera W9, Hera W10 Diagnostic Ultrasound System.
| Device ID | K211824 |
| 510k Number | K211824 |
| Device Name: | HERA W9, HERA W10 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 | 2021-06-14 |
| Decision Date | 2021-09-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809725796869 | K211824 | 000 |
| 08809725796340 | K211824 | 000 |
| 08809725796166 | K211824 | 000 |
| 08809725795985 | K211824 | 000 |