SOPUR GMBH WHEELCHAIRS
FDA 510(k) clearance K911119 · decided 1991-07-16
Clearance details
- K-number
- K911119
- Device name
- SOPUR GMBH WHEELCHAIRS
- Applicant
- Sopur GmbH
- Decision
- Substantially Equivalent
- Date received
- 1991-03-11
- Decision date
- 1991-07-16
- Days to decision
- 127 days
- Clearance type
- Traditional
- Product code
- IOR
- Device class
- 1
- Regulation number
- 890.3850
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Heidelberg, Germany, GR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.