SONICEYE ULTRASOUND TRANSDUCER
FDA 510(k) clearance K113832 · decided 2012-03-06
Clearance details
- K-number
- K113832
- Device name
- SONICEYE ULTRASOUND TRANSDUCER
- Applicant
- Blacktoe Medical Iii, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-12-27
- Decision date
- 2012-03-06
- Days to decision
- 70 days
- Clearance type
- Abbreviated
- Product code
- ITX
- Device class
- 2
- Regulation number
- 892.1570
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Beaverton, OR, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.