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 Sv70 Ventilator
510(k) Number K053607
Device Name BREAS VIVO 40 SYSTEM
Applicant
Breas Medical AB
Foretagsvagen 1
Molnlycke, Vastra Gotaland,  SE SE-435 33
Applicant Contact KARL-JOHAN HOLM
Correspondent
Breas Medical AB
Foretagsvagen 1
Molnlycke, Vastra Gotaland,  SE SE-435 33
Correspondent Contact KARL-JOHAN HOLM
Regulation Number868.5895
Classification Product Code
MNT  
Date Received12/27/2005
Decision Date 03/16/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-