The following data is part of a premarket notification filed by Samsung Medison Co., Ltd with the FDA for Ugeo H70c Diagnostic Ultrasound System.
| Device ID | K130803 |
| 510k Number | K130803 |
| Device Name: | UGEO H70C DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | SAMSUNG MEDISON CO., LTD 42, TEHERAN-RO 108-GIL GANGNAM-GU Seoul, KR |
| Contact | Kyeong-mi Park |
| 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 | 2013-03-22 |
| Decision Date | 2013-04-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806167744908 | K130803 | 000 |