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 generator, oxygen, portable
510(k) Number K162433
Device Name GCE Zen-O Portable Oxygen Concentrator
Applicant
OXUS, INC
2676 PALDAN
AUBURN HILLS,  MI  48326
Applicant Contact RYAN LENARCIC
Correspondent
OXUS, INC
2676 PALDAN
AUBURN HILLS,  MI  48326
Correspondent Contact RYAN LENARCIC
Regulation Number868.5440
Classification Product Code
CAW  
Date Received08/31/2016
Decision Date 05/24/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-