NeuroQ 3.8
FDA 510(k) clearance K180077 · decided 2018-08-16
Clearance details
- K-number
- K180077
- Device name
- NeuroQ 3.8
- Applicant
- Syntermed
- Decision
- Substantially Equivalent
- Date received
- 2018-01-10
- Decision date
- 2018-08-16
- Days to decision
- 218 days
- Clearance type
- Traditional
- Product code
- KPS
- Device class
- 2
- Regulation number
- 892.1200
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Anaheim, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.