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 Ventilator, Continuous, Facility Use
510(k) Number K183364
Device Name Bellavista
Applicant
Imtmedical AG
Gewerbestrasse 8
Buchs SG,  CH 9470
Applicant Contact Beat Keller
Correspondent
Vyaire Medical
26125 N. Riverwoods Blvd.
Mettawa,  IL  60045
Correspondent Contact Colleen Watson
Regulation Number868.5895
Classification Product Code
CBK  
Date Received12/04/2018
Decision Date 09/13/2019
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
Recalls CDRH Recalls
-
-