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 Unit, Liquid-Oxygen, Portable
510(k) Number K130068
Device Name DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS)
Applicant
ESSEX INDUSTRIES, INC. D/B/A ESSEX CRYOGENICS OF M
8007 CHIVVIS DRIVE
ST. LOUIS,  MO  63123 -2395
Applicant Contact KEN SEISE
Correspondent
ESSEX INDUSTRIES, INC. D/B/A ESSEX CRYOGENICS OF M
8007 CHIVVIS DRIVE
ST. LOUIS,  MO  63123 -2395
Correspondent Contact KEN SEISE
Regulation Number868.5655
Classification Product Code
BYJ  
Date Received01/11/2013
Decision Date 07/19/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-