A-View
FDA 510(k) clearance K170338 · decided 2017-05-16
Clearance details
- K-number
- K170338
- Device name
- A-View
- Applicant
- Stroke2prevent B.V.
- Decision
- Substantially Equivalent
- Date received
- 2017-02-02
- Decision date
- 2017-05-16
- Days to decision
- 103 days
- Clearance type
- Traditional
- Product code
- ITX
- Device class
- 2
- Regulation number
- 892.1570
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- 8025 Az Zwolle, NL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.