EVERYTIME TRANSFUCER COVER
FDA 510(k) clearance K955893 · decided 1997-12-30
Clearance details
- K-number
- K955893
- Device name
- EVERYTIME TRANSFUCER COVER
- Applicant
- Amedic AB
- Decision
- Substantially Equivalent
- Date received
- 1995-12-15
- Decision date
- 1997-12-30
- Days to decision
- 746 days
- Clearance type
- Traditional
- Product code
- ITX
- Device class
- 2
- Regulation number
- 892.1570
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Sollentuna, SE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.