The following data is part of a premarket notification filed by Advanced Instrumentations, Inc with the FDA for Dus-7000 Digital Color Doppler Ultrasound System.
Device ID | K172055 |
510k Number | K172055 |
Device Name: | DUS-7000 Digital Color Doppler Ultrasound System |
Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant | Advanced Instrumentations, Inc 6800 NW 77th Ct Miami, FL 33166 |
Contact | Jorge Millan |
Correspondent | Jorge Millan Advanced Instrumentations, Inc 6800 NW 77th Ct Miami, FL 33166 |
Product Code | IYN |
Subsequent Product Code | ITX |
Subsequent Product Code | IYO |
CFR Regulation Number | 892.1550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-07-06 |
Decision Date | 2017-08-31 |