The following data is part of a premarket notification filed by Vinno Technology (suzhou) Co., Ltd. with the FDA for Vinno 8, Vinno 6, Vinno 5.
Device ID | K190120 |
510k Number | K190120 |
Device Name: | VINNO 8, VINNO 6, VINNO 5 |
Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant | VINNO Technology (Suzhou) Co., Ltd. 5F Building A, 4F Building C No. 27 XinFa Rd. Suzhou Industrial Park Suzhou, CN 215123 |
Contact | Wei Wang |
Correspondent | Sherry Zhang VINNO Technology (Suzhou) Co., Ltd. 5F Building A, 4F Building C No. 27 XinFa Rd. Suzhou Industrial Park Suzhou, CN 215123 |
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 | 2019-01-24 |
Decision Date | 2020-01-23 |