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 Regulator, Pressure, Gas Cylinder
510(k) Number K894302
Device Name OXYGEN THERAPY REGULATOR
Applicant
Modern Engineering Co., Inc.
P.O. Box 31725
St. Louis,  MO  63131
Applicant Contact JAMES FAUSEK
Correspondent
Modern Engineering Co., Inc.
P.O. Box 31725
St. Louis,  MO  63131
Correspondent Contact JAMES FAUSEK
Regulation Number868.2700
Classification Product Code
CAN  
Date Received05/03/1989
Decision Date 08/07/1989
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
-
-