HeartSee— 510(k) K143664

Name: FDA 510(k) clearance K143664
Creator: U.S. Food and Drug Administration
Published: 2015-04-14

Substantially Equivalent

University of Texas Medical School AT Houston

FDA 510(k) clearance K143664 for HeartSee, Substantially Equivalent on 2015-04-14. Applicant: University of Texas Medical School AT Houston. Device class: 2.

Clearance details

Applicant: University of Texas Medical School AT Houston
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2014-12-23
Decision date: 2015-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

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