• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
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 K122350
Device Name TAP PAP NASAL PILLOW MASK
Original Applicant
AIRWAY MANAGEMENT, INC.
24301 woodsage drive
bonita springs,  FL  34134
Original Contact paul dryden
Regulation Number868.5905
Classification Product Code
BZD  
Date Received08/03/2012
Decision Date 11/01/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-