The following data is part of a premarket notification filed by Sonoscanner with the FDA for U-lite Exp.
Device ID | K171164 |
510k Number | K171164 |
Device Name: | U-Lite EXP |
Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant | Sonoscanner 6 Rue Andre Voguet Ivry Sur Seine, FR 94200 |
Contact | Bruno Richard |
Correspondent | E. J. Smith Smith Associates 1468 Harwell Avenue Crofton, MD 21114 |
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 | 2017-04-20 |
Decision Date | 2017-08-03 |
Summary: | summary |