The following data is part of a premarket notification filed by Samsung Medison Co., Ltd. with the FDA for Rs80 Evo Diagnostic Ultrasound System.
Device ID | K192030 |
510k Number | K192030 |
Device Name: | RS80 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 | 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 | 2019-07-30 |
Decision Date | 2019-09-19 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08809521024562 | K192030 | 000 |
08809521024470 | K192030 | 000 |