The following data is part of a premarket notification filed by Medison Co., Ltd. with the FDA for Eko 7 Diagnostic Ultrasound System.
Device ID | K101455 |
510k Number | K101455 |
Device Name: | EKO 7 DIAGNOSTIC ULTRASOUND SYSTEM |
Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant | MEDISON CO., LTD. 1003 DAECHI-DONG GANGNAM-GU Seoul, KR 135-280 |
Contact | Kyung-am Shim |
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 | 2010-05-25 |
Decision Date | 2010-07-19 |
Summary: | summary |