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) | Registration & Listing | Adverse Events | Recalls | PMA | 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, facility use
510(K) Number K122560
Model MODEL V1
Device Name VERSALVENT MODEL V1 HYPERBARIC CHAMBER VENTILATOR MODEL V1
Applicant
PAN-AMERICA HYPERBARICS, INC.
1510 park place drive
atchison,  KS  66002
Contact william m gates, rrt
Regulation Number868.5895
Classification Product Code
CBK  
Date Received08/22/2012
Decision Date 03/26/2013
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
-
-