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 Holder, Infant Position
510(k) Number K062143
Device Name KOZY COMFORT INFANT POSITIONER
Applicant
Alfred E Mann Inst. For Biomedical Engineering
1042 Downey Way, Drb 101
Los Angeles,  CA  90089 -1112
Applicant Contact ARMAN H NADERSHAHI
Correspondent
Alfred E Mann Inst. For Biomedical Engineering
1042 Downey Way, Drb 101
Los Angeles,  CA  90089 -1112
Correspondent Contact ARMAN H NADERSHAHI
Regulation Number880.5680
Classification Product Code
FRP  
Date Received07/27/2006
Decision Date 10/24/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-