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 Nebulizer (Direct Patient Interface)
510(k) Number K042991
Device Name I-NEB AAD SYSTEM
Applicant
Profile Therapeutics Plc
Corporate Services
1010 Murry Ridge Lane
Murrysville,  PA  15668 -8525
Applicant Contact BARBARA CAMPBELL
Correspondent
Profile Therapeutics Plc
Corporate Services
1010 Murry Ridge Lane
Murrysville,  PA  15668 -8525
Correspondent Contact BARBARA CAMPBELL
Regulation Number868.5630
Classification Product Code
CAF  
Date Received11/01/2004
Decision Date 09/23/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-