The following data is part of a premarket notification filed by Samsung Medison Co, Ltd. with the FDA for Hs40 Diagnostic Ultrasound System.
| Device ID | K180409 |
| 510k Number | K180409 |
| Device Name: | HS40 Diagnostic Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Samsung Medison Co, Ltd. 3366, Hanseo-ro, Nam-myeon, Hongcheon-gun Gangwon-do, KR 25108 |
| Contact | Ji Yea Lee |
| Correspondent | Ji Yea Lee Samsung Medison Co, Ltd. 3366, Hanseo-ro, Nam-myeon, Hongcheon-gun Gangwon-do, 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 | 2018-02-14 |
| Decision Date | 2018-05-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806167791056 | K180409 | 000 |
| 08806167790837 | K180409 | 000 |
| 08806167790790 | K180409 | 000 |
| 08806167790646 | K180409 | 000 |
| 08806167759933 | K180409 | 000 |
| 08806167759896 | K180409 | 000 |
| 08806167759872 | K180409 | 000 |
| 08806167759865 | K180409 | 000 |
| 08809702980571 | K180409 | 000 |