• 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 heater, breathing system w/wo controller (not humidifier or nebulizer
510(k) Number K851245
Device Name ADDITION OF 50% OXYGEN TO APPLINC SAVING BREATH HY
Applicant
APPLINC
7677 RONSON RD STE 108
SAN DIEGO,  CA  92102
Applicant Contact ERNESTO R AVILES
Correspondent
APPLINC
7677 RONSON RD STE 108
SAN DIEGO,  CA  92102
Correspondent Contact ERNESTO R AVILES
Regulation Number868.5270
Classification Product Code
BZE  
Date Received03/27/1985
Decision Date 05/15/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-