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 | K152962 |
510k Number | K152962 |
Device Name: | HS70A Diagnostic Ultrasound System |
Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant | SAMSUNG MEDISON CO., LTD. 42, TEHERAN-RO 108-GIL Gangnam-gu, KR 135-280 |
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 | 2015-10-07 |
Decision Date | 2015-11-02 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08809702986429 | K152962 | 000 |
08809702985484 | K152962 | 000 |
08809702981790 | K152962 | 000 |
08806167765743 | K152962 | 000 |
08806167765941 | K152962 | 000 |