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 | K173513 |
510k Number | K173513 |
Device Name: | WS80A Diagnostic Ultrasound System |
Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant | Samsung Medison Co., Ltd. 42, Teheran-ro 108-gil Seoul, KR 06176 |
Contact | Ji Yea Lee |
Correspondent | Ji Yea Lee Samsung Medison Co., Ltd. 42, Teheran-ro 108-gil Seoul, KR 06176 |
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 | 2017-11-13 |
Decision Date | 2018-02-20 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08806167780081 | K173513 | 000 |