SOLID GEL PAD
FDA 510(k) clearance K131905 · decided 2013-07-18
Clearance details
- K-number
- K131905
- Device name
- SOLID GEL PAD
- Applicant
- Bluemtech
- Decision
- Substantially Equivalent
- Date received
- 2013-06-26
- Decision date
- 2013-07-18
- Days to decision
- 22 days
- Clearance type
- Traditional
- Product code
- MUI
- Device class
- 2
- Regulation number
- 892.1570
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Anaheim, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.