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 Restraint, Protective
510(k) Number K081264
Device Name STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002
Applicant
Children'S Health First, Inc.
5249 Shelley Pl.
Carlsbad,  CA  92008
Applicant Contact ROGER T VAUGHAN
Correspondent
Children'S Health First, Inc.
5249 Shelley Pl.
Carlsbad,  CA  92008
Correspondent Contact ROGER T VAUGHAN
Regulation Number880.6760
Classification Product Code
FMQ  
Date Received05/05/2008
Decision Date 02/13/2009
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
-
-