The following data is part of a premarket notification filed by Samsung Medison Co., Ltd. with the FDA for Hs70a Diagnostic Ultrasound System.
| Device ID | K163691 |
| 510k Number | K163691 |
| Device Name: | HS70A Diagnostic Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Samsung Medison Co., Ltd. 42, Teheran-ro 108-gil Gangnam-gu Seoul, KR 06176 |
| Contact | Emily Woo |
| 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 | 2016-12-28 |
| Decision Date | 2017-02-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806167789817 | K163691 | 000 |
| 08809702986740 | K163691 | 000 |
| 08809702985828 | K163691 | 000 |
| 08809702985910 | K163691 | 000 |
| 08809702987051 | K163691 | 000 |
| 08806167764166 | K163691 | 000 |
| 08806167788834 | K163691 | 000 |
| 08806167789008 | K163691 | 000 |
| 08806167789176 | K163691 | 000 |
| 08806167788643 | K163691 | 000 |