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 Ventilator, Continuous, Facility Use
510(k) Number K053502
Device Name NEWPORT E360 VENTILATOR
Applicant
Newport Medical Instruments, Inc.
1620 Sunflower Ave.
Costa Mesa,  CA  92626
Applicant Contact RICHARD WATERS
Correspondent
Newport Medical Instruments, Inc.
1620 Sunflower Ave.
Costa Mesa,  CA  92626
Correspondent Contact RICHARD WATERS
Regulation Number868.5895
Classification Product Code
CBK  
Date Received12/16/2005
Decision Date 01/10/2006
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
-
-