Home / 510(k) Clearances / K181363

510(k) K181363

EcoVue Sterile and Non-Sterile Ultrasound Gels by H R Pharmaceuticals, Inc. — Product Code MUI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2018
Date Received
May 23, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances by H R Pharmaceuticals, Inc.

  • K200556 — AquaFlate Pre-Filled Sterile Water Syringe 10mL (March 31, 2020)

Other clearances for product code MUI

  • K242167 — Sterile and Non-Sterile Ultrasonic Coupling Agent (September 19, 2024)
  • K241789 — Non-Sterile Ultrasound Transmission Gels (July 24, 2024)
  • K232957 — Sterile and Non-Sterile Ultrasound Gels (December 15, 2023)
  • K221999 — Ultrasound Transmission Gels (August 30, 2022)
  • K211691 — Ultrast Gel (December 22, 2021)
  • K190591 — Safergel Sterile Ultrasound Gel (October 4, 2019)
  • K163027 — Ultra/Phonic Free Conductivity Gel (January 9, 2018)
  • K163026 — Ultra/Phonic Scanning Gel (January 9, 2018)
  • K163023 — Other-Sonic Transmission Gel (January 8, 2018)
  • K163024 — Ultra/Phonic Conductivity Gel (January 8, 2018)