The following data is part of a premarket notification filed by Ventripoint, Inc. with the FDA for Ventripoint Medical System.
| Device ID | K150628 |
| 510k Number | K150628 |
| Device Name: | VentriPoint Medical System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | VENTRIPOINT, INC. 1805 136TH PI NE, SUITE 101 Bellevue, WA 98005 |
| Contact | Jim Bodtke |
| Correspondent | Jim Bodtke VENTRIPOINT, INC. 1805 136TH PI NE, SUITE 101 Bellevue, WA 98005 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-11 |
| Decision Date | 2015-05-22 |
| Summary: | summary |