The following data is part of a premarket notification filed by Chison Medical Imaging Co., Ltd. with the FDA for Chison Diagnostic Ultrasound System.
Device ID | K120801 |
510k Number | K120801 |
Device Name: | CHISON DIAGNOSTIC ULTRASOUND SYSTEM |
Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant | CHISON MEDICAL IMAGING CO., LTD. 7263 CRONIN CIRCLE Dublin, CA 94568 |
Contact | Bob Leiker |
Correspondent | Bob Leiker CHISON MEDICAL IMAGING CO., LTD. 7263 CRONIN CIRCLE Dublin, CA 94568 |
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 | No |
Combination Product | No |
Date Received | 2012-03-16 |
Decision Date | 2012-06-14 |
Summary: | summary |