SHUNTCHECK - CSF SHUNT FLOW DETECTOR
FDA 510(k) clearance K080168 · decided 2008-05-16
Clearance details
- K-number
- K080168
- Device name
- SHUNTCHECK - CSF SHUNT FLOW DETECTOR
- Applicant
- Neuro Diagnostic Devices
- Decision
- Substantially Equivalent
- Date received
- 2008-01-23
- Decision date
- 2008-05-16
- Days to decision
- 114 days
- Clearance type
- Traditional
- Product code
- JXG
- Device class
- 2
- Regulation number
- 882.5550
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Trevose, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.