The following data is part of a premarket notification filed by Ventripoint Diagnostics, Ltd. with the FDA for Ventripoint Medical System Plus (vms+).
| Device ID | K173810 |
| 510k Number | K173810 |
| Device Name: | Ventripoint Medical System Plus (VMS+) |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Ventripoint Diagnostics, Ltd. 2 Sheppard Avenue East, Suite 605 Toronto, CA M2n 5y7 |
| Contact | Desmond Hirson |
| Correspondent | Desmond Hirson Ventripoint Diagnostics, Ltd. 2 Sheppard Avenue East, Suite 605 Toronto, CA M2n 5y7 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-15 |
| Decision Date | 2018-05-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07540263000018 | K173810 | 000 |