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 K941145
Device Name OXY-GENERATOR
Applicant
MED SYSTEMS
2510 ARIZONA AVE STE 8
SANTA MONICA,  CA  90404
Applicant Contact JIM DAVIS
Correspondent
MED SYSTEMS
2510 ARIZONA AVE STE 8
SANTA MONICA,  CA  90404
Correspondent Contact JIM DAVIS
Regulation Number868.5440
Classification Product Code
CAW  
Date Received03/10/1994
Decision Date 09/27/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-