VERTIS PNT CONTROL UNIT, VERTIS PNT SAFEGUIDE KIDS, MODELS CU100, SGXXX
FDA 510(k) clearance K011702 · decided 2001-12-21
Clearance details
- K-number
- K011702
- Device name
- VERTIS PNT CONTROL UNIT, VERTIS PNT SAFEGUIDE KIDS, MODELS CU100, SGXXX
- Applicant
- Vertis Neuroscience, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-06-01
- Decision date
- 2001-12-21
- Days to decision
- 203 days
- Clearance type
- Traditional
- Product code
- NHI
- Device class
- 2
- Regulation number
- 882.5890
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Seattle, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.