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 Vaporizer, Anesthesia, Non-Heated
510(k) Number K942545
Device Name SIGMA ELITE
Applicant
Penlon , Ltd.
Abingdon Ox 14 3ph
Abingdon Ox,  GB
Applicant Contact A. C GREEN
Correspondent
Penlon , Ltd.
Abingdon Ox 14 3ph
Abingdon Ox,  GB
Correspondent Contact A. C GREEN
Regulation Number868.5880
Classification Product Code
CAD  
Date Received05/31/1994
Decision Date 02/03/1995
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
-
-