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 Filter, Bacterial, Breathing-Circuit
510(k) Number K002839
Device Name END EXPIRATORY FILTER, MODEL RT020
Applicant
Fisher & Paykel Healthcare, Ltd.
15 Maurice Paykel Pl.
East Tamaki, Auckland,  NZ
Applicant Contact CHRIS MANDER
Correspondent
Fisher & Paykel Healthcare, Ltd.
15 Maurice Paykel Pl.
East Tamaki, Auckland,  NZ
Correspondent Contact CHRIS MANDER
Regulation Number868.5260
Classification Product Code
CAH  
Date Received09/12/2000
Decision Date 10/04/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-