The following data is part of a premarket notification filed by Ventripoint, Inc. with the FDA for Ventripoint Medical System.
| Device ID | K140153 |
| 510k Number | K140153 |
| Device Name: | VENTRIPOINT MEDICAL SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | VENTRIPOINT, INC. 24 ROY ST. #445 Seattle, WA 98109 |
| Contact | Jim Bodtke |
| Correspondent | Jim Bodtke VENTRIPOINT, INC. 24 ROY ST. #445 Seattle, WA 98109 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-22 |
| Decision Date | 2014-03-06 |
| Summary: | summary |