• 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 K971889
Device Name CHAD TOTAL O2 DELIVERY SYSTEM
Applicant
CHAD THERAPEUTICS, INC.
21622 PLUMMER ST.
CHATSWORTH,  CA  91311
Applicant Contact LOUIE GORYOKA
Correspondent
CHAD THERAPEUTICS, INC.
21622 PLUMMER ST.
CHATSWORTH,  CA  91311
Correspondent Contact LOUIE GORYOKA
Regulation Number868.5440
Classification Product Code
CAW  
Date Received05/21/1997
Decision Date 11/17/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-