The following data is part of a premarket notification filed by Medison Co., Ltd. with the FDA for Sonoace 4500 Diagnostic Ultrasound Imaging System.
Device ID | K910342 |
510k Number | K910342 |
Device Name: | SONOACE 4500 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM |
Classification | System, Imaging, Pulsed Echo, Ultrasonic |
Applicant | MEDISON CO., LTD. 148 YANG DUK WON-RI, NAM-MYUN, HONG CHUN-KUN Kang Won-do, KR |
Contact | Robert D Waxham |
Correspondent | Robert D Waxham MEDISON CO., LTD. 148 YANG DUK WON-RI, NAM-MYUN, HONG CHUN-KUN Kang Won-do, KR |
Product Code | IYO |
CFR Regulation Number | 892.1560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-01-28 |
Decision Date | 1991-08-19 |