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510(k) K030889

ULTRAEKOGEL MODELS EK 2000 & EK 2001 by Inmed Ltda. — Product Code MUI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 2003
Date Received
March 21, 2003
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

Other clearances by Inmed Ltda.

  • K030081 — CSF400 AND CSF600 (October 6, 2003)
  • K030887 — LEKTROGEL, MODEL LK3001 (June 13, 2003)

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  • K221999 — Ultrasound Transmission Gels (August 30, 2022)
  • K211691 — Ultrast Gel (December 22, 2021)
  • K190591 — Safergel Sterile Ultrasound Gel (October 4, 2019)
  • K181363 — EcoVue Sterile and Non-Sterile Ultrasound Gels (June 13, 2018)
  • K163026 — Ultra/Phonic Scanning Gel (January 9, 2018)
  • K163027 — Ultra/Phonic Free Conductivity Gel (January 9, 2018)
  • K163023 — Other-Sonic Transmission Gel (January 8, 2018)