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 Mixer, Breathing Gases, Anesthesia Inhalation
510(k) Number K221494
Device Name Quality Mix Blender, Oxymixer
Applicant
Dehas Medical Systems GmbH
Wesloer Strabe 112
Luebeck,  DE 23568
Applicant Contact Jens Mittendorf
Correspondent
Draeger Medical Systems GmbH
3135 Quarry Rd.
Telford,  PA  18969
Correspondent Contact Tom Hirte
Regulation Number868.5330
Classification Product Code
BZR  
Date Received05/23/2022
Decision Date 01/23/2023
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
-
-