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 K222024
Device Name Evita V800, Evita V600
Applicant
Draegerwerk AG & CO Kgaa
53/55 Moislinger Allee
Luebeck,  DE 23542
Applicant Contact Holger Nadler
Correspondent
Draegerwerk AG & CO Kgaa
53/55 Moislinger Allee
Luebeck,  DE 23542
Correspondent Contact Holger Nadler
Regulation Number868.5895
Classification Product Code
CBK  
Date Received07/11/2022
Decision Date 05/16/2023
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
-
-