FFR Link, FFR Signal Processing Module
FDA 510(k) K170204 · Boston Scientific Corporation
510(k) numberK170204
Submission
- Device name
- FFR Link, FFR Signal Processing Module
- Applicant
- Boston Scientific Corporation
Fremont, CA, US - Received
- January 23, 2017
- Decision date
- March 24, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRG – Transmitters And Receivers, Physiological Signal, Radiofrequency
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2910
- Specialty
- Cardiovascular
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Questions and answers
When was FFR Link, FFR Signal Processing Module cleared by the FDA?
FFR Link, FFR Signal Processing Module (K170204) received a 510(k) decision of Substantially Equivalent on March 24, 2017, 60 days after the submission was received.
What is the product code of K170204?
The FDA product code is DRG – Transmitters And Receivers, Physiological Signal, Radiofrequency, a Class II (moderate risk) device regulated under 21 CFR 870.2910.