The following data is part of a premarket notification filed by Samsung Medison Co., Ltd. with the FDA for Ws80a Diagnostic Ultrasound System.
Device ID | K171070 |
510k Number | K171070 |
Device Name: | WS80A Diagnostic Ultrasound System |
Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant | Samsung Medison Co., Ltd. 42, Teheran-ro 108-gil Seoul, KR |
Contact | Emily Woo |
Correspondent | Emily Woo Samsung Medison Co., Ltd. 42, Teheran-ro 108-gil Seoul, KR |
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 | 2017-04-10 |
Decision Date | 2017-08-09 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08806167780623 | K171070 | 000 |
08806167780463 | K171070 | 000 |
08806167780265 | K171070 | 000 |
08806167765507 | K171070 | 000 |