The following data is part of a premarket notification filed by Samsung Medison Co., Ltd with the FDA for Accuvix A30 Diagnostic Ultrasound System.
Device ID | K112339 |
510k Number | K112339 |
Device Name: | ACCUVIX A30 DIAGNOSTIC ULTRASOUND SYSTEM |
Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant | SAMSUNG MEDISON CO., LTD 1003 DAECHI-DONG, GANGNAM-GU Seoul, 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 | 2011-08-15 |
Decision Date | 2011-08-29 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08806167700416 | K112339 | 000 |
08806167700409 | K112339 | 000 |