ULTRASIGHTHD C31 WITH IMAGESENSE AND REMOTE VIEWER TELEMEDICINE— 510(k) K110147

Name: FDA 510(k) clearance K110147
Creator: U.S. Food and Drug Administration
Published: 2011-04-08

Substantially Equivalent

Sti Medical Systems, LLC

FDA 510(k) clearance K110147 for ULTRASIGHTHD C31 WITH IMAGESENSE AND REMOTE VIEWER TELEMEDICINE, Substantially Equivalent on 2011-04-08. Applicant: Sti Medical Systems, LLC. Device class: 2.

Clearance details

Applicant: Sti Medical Systems, LLC
Product code: Code HEX
Device class: Class 2
Regulation: 21 CFR 884.1630
Advisory panel: Obstetrics/Gynecology
Date received: 2011-01-18
Decision date: 2011-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Jolla, CA, US

Download summary PDF View on FDA.gov ↗

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