SONOSENS
FDA 510(k) clearance K033193 · decided 2004-01-23
Clearance details
- K-number
- K033193
- Device name
- SONOSENS
- Applicant
- Friendly Sensors AG
- Decision
- Substantially Equivalent
- Date received
- 2003-10-02
- Decision date
- 2004-01-23
- Days to decision
- 113 days
- Clearance type
- Abbreviated
- Product code
- NKI
- Device class
- 2
- Regulation number
- 888.1500
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.