• 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 K121597
Device Name ESON NASAL MASK
Original Applicant
FISHER & PAYKEL HEALTHCARE LIMITED
15 maurice paykel place
east tamaki
auckland,  NZ 2013
Original Contact james thompson
Regulation Number868.5905
Classification Product Code
BZD  
Date Received05/31/2012
Decision Date 10/02/2012
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
-
-