The following data is part of a premarket notification filed by Samsung Medison Co., Ltd. with the FDA for Hm70 Evo Diagnostic Ultrasound System.
| Device ID | K210713 |
| 510k Number | K210713 |
| Device Name: | HM70 EVO Diagnostic Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Samsung Medison CO., LTD. 3366, Hanseo-ro, Nam-myeon Hongcheon-gun, KR 25108 |
| Contact | Jee Young Ju |
| 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 | 2021-03-10 |
| Decision Date | 2021-07-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809725794100 | K210713 | 000 |
| 08809725790782 | K210713 | 000 |
| 08809725790966 | K210713 | 000 |
| 08809725791147 | K210713 | 000 |
| 08809725791246 | K210713 | 000 |
| 08809725791420 | K210713 | 000 |
| 08809725791628 | K210713 | 000 |
| 08809725791802 | K210713 | 000 |
| 08809725791987 | K210713 | 000 |
| 08809725792168 | K210713 | 000 |
| 08809725792342 | K210713 | 000 |
| 08809725792601 | K210713 | 000 |
| 08809725792786 | K210713 | 000 |
| 08809725792960 | K210713 | 000 |
| 08809725793066 | K210713 | 000 |
| 08809725793240 | K210713 | 000 |
| 08809725793424 | K210713 | 000 |
| 08809725790607 | K210713 | 000 |