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 Sterilizer, Steam
510(k) Number K141879
Device Name BELIMED STEAM STERILIZER MST-H
Applicant
SAUTER AG
ZELGSTRASSE 8
SULGEN TG,  CH CH-8583
Applicant Contact MICHAEL HARI
Correspondent
SAUTER AG
ZELGSTRASSE 8
SULGEN TG,  CH CH-8583
Correspondent Contact MICHAEL HARI
Regulation Number880.6880
Classification Product Code
FLE  
Date Received07/11/2014
Decision Date 06/17/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-