• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name ventilator, continuous, minimal ventilatory support,facility use
510(k) Number K121623
Device Name BIPAP A 40 VENTILATORY SUPPORT SYSTEM
Original Applicant
RESPIRONICS, INC.
1740 golden mile highway
monroeville,  PA  15146
Original Contact elaine larkin
Regulation Number868.5895
Classification Product Code
MNT  
Date Received06/01/2012
Decision Date 12/14/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
summary summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
-
-