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 K101272
Device Name MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3
Applicant
ESSEX INDUSTRIES, INC.
8007 CHIVVIS DRIVE
ST. LOUIS,  MO  63123
Applicant Contact KEN SEISE
Correspondent
ESSEX INDUSTRIES, INC.
8007 CHIVVIS DRIVE
ST. LOUIS,  MO  63123
Correspondent Contact KEN SEISE
Regulation Number868.5655
Classification Product Code
BYJ  
Date Received05/06/2010
Decision Date 08/20/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-