Search Results
Found 1 results
510(k) Data Aggregation
K Number
K190591Device Name
Safergel Sterile Ultrasound Gel
Manufacturer
Safersonic US, Inc.
Date Cleared
2019-10-04
(211 days)
Product Code
MUI
Regulation Number
892.1570Why did this record match?
Applicant Name (Manufacturer) :
Safersonic US, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Safergel Sterile Ultrasound Gel is a sterile, water-soluble, translucent, clear ultrasonic gel intended for noninterventional and interventional diagnostic and therapeutic ultrasound. Safergel serves the purpose of providing an acoustic bridge for ultrasonic examinations. The gel is intended for use in all diagnostic ultrasound procedures which require coupling gel or fluid.
Device Description
The Safergel Sterile Ultrasound Gel is a sterile, water-soluble, translucent, clear ultrasonic gel intended for noninterventional and interventional diagnostic and therapeutic ultrasound. Safergel serves the purpose of providing an acoustic bridge for ultrasonic examinations. The gel is intended for use in all diagnostic ultrasound procedures which require coupling gel or fluid.
Ask a Question
Page 1 of 1