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 K093633
Device Name INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE
Applicant
Draegerwerk AG & Co. KGaA
Moislinger Allee 53-55
Lubeck,  DE 23542
Applicant Contact Nataliia Semenova
Correspondent
Draeger AG & Co. KG
Moislinger Allee 53-55
Lubeck,  DE 23542
Correspondent Contact Dr. Bettina Moebius
Regulation Number868.5895
Classification Product Code
CBK  
Date Received11/23/2009
Decision Date 03/30/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-