FFR Link, FFR Signal Processing Module
FDA 510(k) clearance K170204 · decided 2017-03-24
Clearance details
- K-number
- K170204
- Device name
- FFR Link, FFR Signal Processing Module
- Applicant
- Boston Scientific Corporation
- Decision
- Substantially Equivalent
- Date received
- 2017-01-23
- Decision date
- 2017-03-24
- Days to decision
- 60 days
- Clearance type
- Traditional
- Product code
- DRG
- Device class
- 2
- Regulation number
- 870.2910
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Fremont, CA, US
- Third-party review
- No
- Expedited review
- No
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