The following data is part of a premarket notification filed by Medison Co., Ltd. with the FDA for Accuvix V7 Diagnostic Ultrasound System.
Device ID | K060087 |
510k Number | K060087 |
Device Name: | ACCUVIX V7 DIAGNOSTIC ULTRASOUND SYSTEM |
Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant | MEDISON CO., LTD. 997-10 DAECHI-DONG GUANGNAM-G Seoul, KR 135-280 |
Contact | Kyung-am Shim |
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 | 2006-01-12 |
Decision Date | 2006-01-24 |
Summary: | summary |