• 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 conserver, oxygen
510(k) Number K955129
Device Name OXYPULSE EOC I, EOC II & EOC R
Applicant
EAGLE MEDICAL EQUIPMENT CO.
3134 W. LEWIS #30
PHX,  AZ  85017
Applicant Contact LAWRENCE PELLERITO
Correspondent
EAGLE MEDICAL EQUIPMENT CO.
3134 W. LEWIS #30
PHX,  AZ  85017
Correspondent Contact LAWRENCE PELLERITO
Regulation Number868.5905
Classification Product Code
NFB  
Date Received11/09/1995
Decision Date 02/16/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-