TRANSONIC ELSA SYSTEM
FDA 510(k) clearance K134051 · decided 2015-01-29
Clearance details
- K-number
- K134051
- Device name
- TRANSONIC ELSA SYSTEM
- Applicant
- Transonic Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-12-31
- Decision date
- 2015-01-29
- Days to decision
- 394 days
- Clearance type
- Traditional
- Product code
- DXG
- Device class
- 2
- Regulation number
- 870.1435
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Ithaca, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.