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510(k) K131905

SOLID GEL PAD by Bluemtech — Product Code MUI

K131905 is an FDA 510(k) premarket notification submitted by Bluemtech for the device "SOLID GEL PAD". The FDA issued a decision of Substantially Equivalent on Jul 18, 2013. The device falls under product code MUI (Media, Coupling, Ultrasound), a Class II device regulated under 21 CFR 892.1570.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jul 18, 2013
Date Received
Jun 26, 2013
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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  • K190591 — Safergel Sterile Ultrasound Gel (Oct 4, 2019)
  • K181363 — EcoVue Sterile and Non-Sterile Ultrasound Gels (Jun 13, 2018)
  • K163027 — Ultra/Phonic Free Conductivity Gel (Jan 9, 2018)

FDA data resources