RAPID PROGRAMMER
FDA 510(k) clearance K040609 · decided 2004-03-25
Clearance details
- K-number
- K040609
- Device name
- RAPID PROGRAMMER
- Applicant
- Advanced Neuromodulation Systems
- Decision
- Substantially Equivalent
- Date received
- 2004-03-08
- Decision date
- 2004-03-25
- Days to decision
- 17 days
- Clearance type
- Special
- Product code
- GZB
- Device class
- 2
- Regulation number
- 882.5880
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Plano, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.