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, Non-Life-Supporting
510(k) Number K092818
Device Name BIPAP AVAPS VENTILATORY SUPPORT SYSTEM
Applicant
Respironics, Inc.
1740 Golden Mile Highway
Murrysville,  PA  15146
Applicant Contact ZITA A YURKO
Correspondent
Respironics, Inc.
1740 Golden Mile Highway
Murrysville,  PA  15146
Correspondent Contact ZITA A YURKO
Regulation Number868.5895
Classification Product Code
MNS  
Date Received09/14/2009
Decision Date 01/22/2010
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
Recalls CDRH Recalls
-
-