Sensus Healthcare TVM Balloon Applicator— 510(k) K190255

Name: FDA 510(k) clearance K190255
Creator: U.S. Food and Drug Administration
Published: 2019-02-21

Substantially Equivalent

Sensus Healthcare, Inc.

FDA 510(k) clearance K190255 for Sensus Healthcare TVM Balloon Applicator, Substantially Equivalent on 2019-02-21. Applicant: Sensus Healthcare, Inc.. Device class: 2.

Clearance details

Applicant: Sensus Healthcare, Inc.
Product code: Code JAD
Device class: Class 2
Regulation: 21 CFR 892.5900
Advisory panel: Radiology
Date received: 2019-02-07
Decision date: 2019-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boca Raton, FL, US

Download summary PDF View on FDA.gov ↗

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