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 K042262
Device Name INTEGRA OXYGEN CONCENTRATOR, MODEL 6323A-OM-10
Applicant
SEQUAL TECHNOLOGIES, INC.
11436 SORRENTO VALLEY RD.
SAN DIEGO,  CA  92121 -1393
Applicant Contact BRIAN JARRELL
Correspondent
SEQUAL TECHNOLOGIES, INC.
11436 SORRENTO VALLEY RD.
SAN DIEGO,  CA  92121 -1393
Correspondent Contact BRIAN JARRELL
Regulation Number868.5440
Classification Product Code
CAW  
Date Received08/23/2004
Decision Date 09/10/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-