The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Ffr Link, Ffr Signal Processing Module.
| Device ID | K170204 |
| 510k Number | K170204 |
| Device Name: | FFR Link, FFR Signal Processing Module |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | Boston Scientific Corporation 47215 Lakeview Blvd. Fremont, CA 94538 |
| Contact | Dan Krause |
| Correspondent | Dan Krause Boston Scientific Corporation 47215 Lakeview Blvd. Fremont, CA 94538 |
| Product Code | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-23 |
| Decision Date | 2017-03-24 |
| Summary: | summary |