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 K942082
Device Name MODEL 6323 OXYGEN CONCENTRATOR
Applicant
Dynotec Corp.
6323 Nancy Ridge Dr.
San Diego,  CA  92121
Applicant Contact EDWARD A RADTKE
Correspondent
Dynotec Corp.
6323 Nancy Ridge Dr.
San Diego,  CA  92121
Correspondent Contact EDWARD A RADTKE
Regulation Number868.5440
Classification Product Code
CAW  
Date Received04/29/1994
Decision Date 12/08/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-