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

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.

Clearance details

Applicant: Sti Medical Systems, LLC
Product code: Code HEX
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

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