• 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 analyzer, gas, oxygen, gaseous-phase
510(k) Number K973282
Device Name HANDI OXYGEN ANALYZER
Applicant
CERAMATEC, INC.
2425 SOUTH 900 WEST
salt lake city,  UT  84119
Applicant Contact gordon roth
Correspondent
CERAMATEC, INC.
2425 SOUTH 900 WEST
salt lake city,  UT  84119
Correspondent Contact gordon roth
Regulation Number868.1720
Classification Product Code
CCL  
Date Received09/02/1997
Decision Date 03/04/1998
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-