The following data is part of a premarket notification filed by Samsung Medison Co., Ltd. with the FDA for A35 Diagnostic Ultrasound System.
| Device ID | K150478 |
| 510k Number | K150478 |
| Device Name: | A35 Diagnostic Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | SAMSUNG MEDISON CO., LTD. 42, TEHERAN-RO 108-GIL, GANGNAM-GU Seoul, KR |
| Contact | Kim Jiyoung |
| 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 | 2015-02-24 |
| Decision Date | 2015-03-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806167750114 | K150478 | 000 |