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 Ventilator, Non-Continuous (Respirator)
510(k) Number K110471
Device Name BABI PLUS INFANT NASAL CANNULA SYSTEM
Applicant
A Plus Medical
5431 Avenida Encinas
Suite G
Carlsbad,  CA  92008
Applicant Contact THOMAS C LOESCHER
Correspondent
A Plus Medical
5431 Avenida Encinas
Suite G
Carlsbad,  CA  92008
Correspondent Contact THOMAS C LOESCHER
Regulation Number868.5905
Classification Product Code
BZD  
Date Received02/18/2011
Decision Date 10/07/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-