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 Gas-Machine, Anesthesia
510(k) Number K061102
Device Name PRIMA ANAESTHESIA MACHINE
Applicant
Penlon , Ltd.
Abingdon Science Park
Barton Lane, Abingdon,  GB OX14 3NB
Applicant Contact BARRY PEARCE
Correspondent
Penlon , Ltd.
Abingdon Science Park
Barton Lane, Abingdon,  GB OX14 3NB
Correspondent Contact BARRY PEARCE
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received04/19/2006
Decision Date 07/28/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-