FIXIT HEADREST CLAMP SYSTEM
FDA 510(k) clearance K083803 · decided 2010-03-10
Clearance details
- K-number
- K083803
- Device name
- FIXIT HEADREST CLAMP SYSTEM
- Applicant
- Medicon EG
- Decision
- Substantially Equivalent
- Date received
- 2008-12-22
- Decision date
- 2010-03-10
- Days to decision
- 443 days
- Clearance type
- Traditional
- Product code
- HBL
- Device class
- 2
- Regulation number
- 882.4460
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Tuttlingen, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.