The following data is part of a premarket notification filed by Philips Volcano with the FDA for Ffr V2.5.
| Device ID | K170133 |
| 510k Number | K170133 |
| Device Name: | FFR V2.5 |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | Philips Volcano 3721 Valley Ctr. Dr. San Diego, CA 92130 |
| Contact | Elaine Alan |
| Correspondent | Elaine Alan Philips Volcano 3721 Valley Ctr. Dr. San Diego, CA 92130 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-17 |
| Decision Date | 2017-05-26 |
| Summary: | summary |