MODEL GST-1
FDA 510(k) clearance K040193 · decided 2004-04-27
Clearance details
- K-number
- K040193
- Device name
- MODEL GST-1
- Applicant
- Medical Equipment Device Specialists
- Decision
- Substantially Equivalent
- Date received
- 2004-01-28
- Decision date
- 2004-04-27
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- GZJ
- Device class
- 2
- Regulation number
- 882.5890
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Las Vegas, NV, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.