The following data is part of a premarket notification filed by Qisda Corporation with the FDA for Innosight Diagnostic Ultrasound System.
Device ID | K192254 |
510k Number | K192254 |
Device Name: | InnoSight Diagnostic Ultrasound System |
Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant | Qisda Corporation No.157, Shanying Rd, Shan-Ting Li, Gueishan Dist, Taoyuan, TW |
Contact | Johnson Sheu |
Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
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 | Yes |
Combination Product | No |
Date Received | 2019-08-20 |
Decision Date | 2019-09-18 |
Summary: | summary |