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510(k) K190591

Safergel Sterile Ultrasound Gel by Safersonic Us, Inc. — Product Code MUI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 2019
Date Received
March 7, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Coupling, Ultrasound
Device Class
Class II
Regulation Number
892.1570
Review Panel
RA
Submission Type

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  • K211691 — Ultrast Gel (December 22, 2021)
  • K181363 — EcoVue Sterile and Non-Sterile Ultrasound Gels (June 13, 2018)
  • K163027 — Ultra/Phonic Free Conductivity Gel (January 9, 2018)
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  • K163023 — Other-Sonic Transmission Gel (January 8, 2018)
  • K163024 — Ultra/Phonic Conductivity Gel (January 8, 2018)