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 valve, non-rebreathing
510(k) Number K945822
Device Name CAPNO-FLO(TM) REGULATOR
Applicant
KIRK SPECIALTY SYSTEMS
1624 CEWSCENT CIRCLE
SUITE 225
CARROLLTON,  TX  75006
Applicant Contact DALE BICKLEY
Correspondent
KIRK SPECIALTY SYSTEMS
1624 CEWSCENT CIRCLE
SUITE 225
CARROLLTON,  TX  75006
Correspondent Contact DALE BICKLEY
Regulation Number868.5870
Classification Product Code
CBP  
Date Received11/29/1994
Decision Date 02/24/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-