Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Transducer, Ultrasonic, Diagnostic
510(k) Number K153212
Device Name Sheathes Ultrasound Probe Covers
Applicant
Sheathing Technologies, Inc.
18431 Technology Dr.
Morgan Hill,  CA  95037
Applicant Contact JENNIFER DOWNING
Correspondent
Sheating Technologies, Inc.
18431 Technology Dr.
Morgan Hill,  CA  95037
Correspondent Contact JENNIFER DOWNING
Regulation Number892.1570
Classification Product Code
ITX  
Date Received11/05/2015
Decision Date 03/04/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-