PREMIER PLUS
FDA 510(k) clearance K032003 · decided 2004-01-07
Clearance details
- K-number
- K032003
- Device name
- PREMIER PLUS
- Applicant
- American Imex
- Decision
- Substantially Equivalent
- Date received
- 2003-06-27
- Decision date
- 2004-01-07
- Days to decision
- 194 days
- Clearance type
- Traditional
- Product code
- GZJ
- Device class
- 2
- Regulation number
- 882.5890
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.