SOLO-SLED
FDA 510(k) clearance K970090 · decided 1997-04-21
Clearance details
- K-number
- K970090
- Device name
- SOLO-SLED
- Applicant
- Solo-Sled, LLC
- Decision
- Substantially Equivalent
- Date received
- 1997-01-10
- Decision date
- 1997-04-21
- Days to decision
- 101 days
- Clearance type
- Traditional
- Product code
- IXA
- Device class
- 2
- Regulation number
- 892.1850
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Chattanooga, TN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.