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 apparatus, gas-scavenging
510(k) Number K033028
Device Name ANEFIN, MODEL 100
Applicant
AXON MEDICAL
2355 SOUTH 1170 WEST
SUITE D
SALT LAKE CITY,  UT  84119
Applicant Contact JOSEPH ORR
Correspondent
AXON MEDICAL
2355 SOUTH 1170 WEST
SUITE D
SALT LAKE CITY,  UT  84119
Correspondent Contact JOSEPH ORR
Regulation Number868.5430
Classification Product Code
CBN  
Subsequent Product Code
BYW  
Date Received09/26/2003
Decision Date 07/22/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-