The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Diagnostic Ultrasound System.
Device ID | K192791 |
510k Number | K192791 |
Device Name: | Diagnostic Ultrasound System |
Classification | System, Imaging, Pulsed Echo, Ultrasonic |
Applicant | Edan Instruments, Inc. #15 Jinhui Road, Jinsha Community, Kengzi Sub-District Pingshan District Shenzhen, CN 518122 |
Contact | Stella Guo |
Correspondent | Stella Guo Edan Instruments, Inc. #15 Jinhui Road, Jinsha Community, Kengzi Sub-District Pingshan District Shenzhen, CN 518122 |
Product Code | IYO |
Subsequent Product Code | ITX |
Subsequent Product Code | IYN |
CFR Regulation Number | 892.1560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-09-30 |
Decision Date | 2019-11-27 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
06944413812703 | K192791 | 000 |
06944413811461 | K192791 | 000 |
06944413811478 | K192791 | 000 |
06944413811485 | K192791 | 000 |
06944413811492 | K192791 | 000 |
06944413811508 | K192791 | 000 |
06944413811522 | K192791 | 000 |
06944413811546 | K192791 | 000 |
06944413811560 | K192791 | 000 |
06944413811584 | K192791 | 000 |
06944413811744 | K192791 | 000 |
06944413811751 | K192791 | 000 |
06944413812185 | K192791 | 000 |
06944413811454 | K192791 | 000 |