The following data is part of a premarket notification filed by Samsung Medison Co., Ltd. with the FDA for Hs50 / Hs60 Diagnostic Ultrasound System.
| Device ID | K181336 |
| 510k Number | K181336 |
| Device Name: | HS50 / HS60 Diagnostic Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Samsung Medison Co., Ltd. 3366, Hanseo-ro, Nam-myeon Hongcheon-gun, KR 25108 |
| Contact | Ji Yea Lee |
| Correspondent | Ji Yea Lee 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 | 2018-05-21 |
| Decision Date | 2018-12-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806167794828 | K181336 | 000 |
| 08806167792572 | K181336 | 000 |
| 08806167792763 | K181336 | 000 |
| 08806167792954 | K181336 | 000 |
| 08806167793142 | K181336 | 000 |
| 08806167793333 | K181336 | 000 |
| 08806167793883 | K181336 | 000 |
| 08806167794071 | K181336 | 000 |
| 08806167794262 | K181336 | 000 |
| 08806167794453 | K181336 | 000 |
| 08806167794637 | K181336 | 000 |
| 08806167792381 | K181336 | 000 |