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, Non-Continuous (Respirator)
510(k) Number K023559
Device Name FISHER & PAYKEL HEALTHECARE ORACLE ORAL MASK
Applicant
Fisher &Paykel Healthcare , Ltd.
P.O Box 14-348
Panmure, Auckland,  NZ 1701
Applicant Contact KEVIN SHERLOCK
Correspondent
Fisher &Paykel Healthcare , Ltd.
P.O Box 14-348
Panmure, Auckland,  NZ 1701
Correspondent Contact KEVIN SHERLOCK
Regulation Number868.5905
Classification Product Code
BZD  
Date Received10/23/2002
Decision Date 06/12/2003
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
-
-