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 K110383
Device Name BABI*PLUS PRESSURE RELIEF MANIFOLD - 10CM H20, 12.5CM H20, 15CM H20
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 Received02/10/2011
Decision Date 08/01/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-