The following data is part of a premarket notification filed by Samsung Medison Co., Ltd. with the FDA for Hm70a Diagnostic Ultrasound System.
| Device ID | K182894 |
| 510k Number | K182894 |
| Device Name: | HM70A 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 | 2018-10-15 |
| Decision Date | 2019-01-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806167795047 | K182894 | 000 |
| 08806167795054 | K182894 | 000 |
| 08806167798147 | K182894 | 000 |
| 08806167788377 | K182894 | 000 |
| 08806167781279 | K182894 | 000 |
| 08809702985880 | K182894 | 000 |
| 08809725781582 | K182894 | 000 |