The following data is part of a premarket notification filed by Sonoscanner with the FDA for T-lite.
Device ID | K201988 |
510k Number | K201988 |
Device Name: | T-Lite |
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 Assoicates 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 | 2020-07-17 |
Decision Date | 2020-10-30 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
03701104600161 | K201988 | 000 |
03701104600154 | K201988 | 000 |
03701104600147 | K201988 | 000 |
03701104600130 | K201988 | 000 |
03701104600123 | K201988 | 000 |
03701104600116 | K201988 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() T-LITE 88476971 not registered Live/Pending |
Soteria Biotherapeutics, Inc. 2019-06-17 |
![]() T-LITE 79012151 3090500 Dead/Cancelled |
BASF SE 2005-05-27 |
![]() T-LITE 74687323 1982435 Live/Registered |
TACONY CORPORATION 1995-06-12 |
![]() T-LITE 74503403 1888184 Dead/Cancelled |
T-LITE CORPORATION 1994-03-18 |
![]() T-LITE 73256640 1167145 Live/Registered |
Transistolite Manufacturing Limited 1980-04-03 |
![]() T-LITE 73051845 1044006 Dead/Expired |
THOMSON-LEEDS COMPANY INC. 1975-05-08 |