510(k) K170204
K170204 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "FFR Link, FFR Signal Processing Module". The FDA issued a decision of Substantially Equivalent on Mar 24, 2017. The device falls under product code DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency), a Class II device regulated under 21 CFR 870.2910. Boston Scientific Corporation has 238 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 24, 2017
- Date Received
- Jan 23, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transmitters And Receivers, Physiological Signal, Radiofrequency
- Device Class
- Class II
- Regulation Number
- 870.2910
- Review Panel
- CV
- Submission Type
- 510(k)