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 K003472
Device Name INTEGRA OXYGEN CONCENTRATORS MODEL 6400-OM
Applicant
SEQUAL TECHNOLOGIES, INC.
11436 SORRENTO VALLEY RD.
SAN DIEGO,  CA  92121
Applicant Contact RON HALL
Correspondent
SEQUAL TECHNOLOGIES, INC.
11436 SORRENTO VALLEY RD.
SAN DIEGO,  CA  92121
Correspondent Contact RON HALL
Regulation Number868.5440
Classification Product Code
CAW  
Date Received11/08/2000
Decision Date 06/04/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-