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510(k) K091828

SHEATHESISO ULTRASOUND TRANSDUCER COVER by Sheathing Technologies, Inc. — Product Code ITX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 2009
Date Received
June 19, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Ultrasonic, Diagnostic
Device Class
Class II
Regulation Number
892.1570
Review Panel
RA
Submission Type

Other clearances by Sheathing Technologies, Inc.

  • K153212 — Sheathes Ultrasound Probe Covers (March 4, 2016)
  • K130041 — SHEATHES STERILE ULTRASOUND GEL (February 6, 2013)
  • K112827 — SHEATHES ULTRASOND GEL (June 22, 2012)
  • K100966 — COLONOSCOPE/SIGMOIDOSCOPE SHEATHES (August 3, 2010)
  • K043425 — SHEATHES NEEDLE GUIDE, MODEL NG-SR-A-484-KIT (THERE WILL BE VARIOUS MODEL NUMBER (February 28, 2005)
  • K990175 — SHEATHES (NON-LATEX), STERILE (April 21, 1999)

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  • K231783 — VitroPRO (November 14, 2023)