SHEATHES STERILE ULTRASOUND GEL— 510(k) K130041

Name: FDA 510(k) clearance K130041
Creator: U.S. Food and Drug Administration
Published: 2013-02-06

Substantially Equivalent

Sheathing Technologies, Inc.

FDA 510(k) clearance K130041 for SHEATHES STERILE ULTRASOUND GEL, Substantially Equivalent on 2013-02-06. Applicant: Sheathing Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Sheathing Technologies, Inc.
Product code: Code MUI
Device class: Class 2
Regulation: 21 CFR 892.1570
Advisory panel: Radiology
Date received: 2013-01-08
Decision date: 2013-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morgan Hill, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.