The following data is part of a premarket notification filed by Samsung Medison Co., Ltd with the FDA for Ugeo Pt60a Diagnostic Ultrasound System.
Device ID | K142466 |
510k Number | K142466 |
Device Name: | UGEO PT60A Diagnostic Ultrasound System |
Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant | SAMSUNG MEDISON CO., LTD 42, TEHERAN-RO 108-GIL, Gangnam-gu, KR |
Contact | Park Kyeong-mi |
Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
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 | Yes |
Combination Product | No |
Date Received | 2014-09-02 |
Decision Date | 2014-10-03 |
Summary: | summary |