NEURO CHECK DEVICE WITH IO-FLEX WIRE
FDA 510(k) clearance K113533 · decided 2012-04-11
Clearance details
- K-number
- K113533
- Device name
- NEURO CHECK DEVICE WITH IO-FLEX WIRE
- Applicant
- Baxano, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-11-30
- Decision date
- 2012-04-11
- Days to decision
- 133 days
- Clearance type
- Special
- Product code
- HAE
- Device class
- 2
- Regulation number
- 882.4840
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.