MODEL SW-103 SOLITANS STIMULATOR
FDA 510(k) clearance K904264 · decided 1991-05-09
Clearance details
- K-number
- K904264
- Device name
- MODEL SW-103 SOLITANS STIMULATOR
- Applicant
- Medical Consultants Intl. , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1990-09-18
- Decision date
- 1991-05-09
- Days to decision
- 233 days
- Clearance type
- Traditional
- Product code
- GZJ
- Device class
- 2
- Regulation number
- 882.5890
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Glen Rock, NJ, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| Clinac High Energy Medical Linear Accelerator, Medical Charged-particle radiation therapy recall (Z-0194-2007) | Varian Medical Systems Inc | 2006-11-16 |