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 | K220269 |
| 510k Number | K220269 |
| 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, KP 25108 |
| Contact | Ju Jee Young |
| Correspondent | Jee Young Ju Samsung Medison Co., Ltd. 3366, Hanseo-ro, Nam-myeon Hongcheon-gun, KP 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 | 2022-01-31 |
| Decision Date | 2022-05-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809725819070 | K220269 | 000 |
| 08809702981738 | K220269 | 000 |
| 08809725815041 | K220269 | 000 |
| 08809725817076 | K220269 | 000 |
| 08809725817250 | K220269 | 000 |
| 08809725817434 | K220269 | 000 |
| 08809725817618 | K220269 | 000 |
| 08809725817793 | K220269 | 000 |
| 08809725817977 | K220269 | 000 |
| 08809725818158 | K220269 | 000 |
| 08809725818332 | K220269 | 000 |
| 08809725818530 | K220269 | 000 |
| 08809725818714 | K220269 | 000 |
| 08809725818899 | K220269 | 000 |
| 08809725796647 | K220269 | 000 |