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 K122847
Device Name KANGAROO NASAL MASK
Applicant
RESPIRONICS INC.
1001 MURRY RIDGE LANE
MURRYSVILLE,  PA  15668
Applicant Contact MICHELLE BRINKER
Correspondent
RESPIRONICS INC.
1001 MURRY RIDGE LANE
MURRYSVILLE,  PA  15668
Correspondent Contact MICHELLE BRINKER
Regulation Number868.5905
Classification Product Code
BZD  
Date Received09/18/2012
Decision Date 03/06/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-