Sensus Healthcare TVM Balloon Applicator— 510(k) K190255
Substantially EquivalentSensus Healthcare, Inc.
FDA 510(k) clearance K190255 for Sensus Healthcare TVM Balloon Applicator, Substantially Equivalent on 2019-02-21. Applicant: Sensus Healthcare, Inc..
Clearance details
- Applicant
- Sensus Healthcare, Inc.
- Product code
- Code JAD
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boca Raton, FL, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.