SCANTEC PAD
FDA 510(k) clearance K031894 · decided 2003-07-18
Clearance details
- K-number
- K031894
- Device name
- SCANTEC PAD
- Applicant
- Sonotech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-06-19
- Decision date
- 2003-07-18
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- MUI
- Device class
- 2
- Regulation number
- 892.1570
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Bellingham, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.