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 Warmer, Infant Radiant
510(k) Number K201628
Device Name Panda iRes Warmer, Giraffe Warmer
Applicant
Ge Healthcare
9900 Innovation Dr.
Wauwatosa,  WI  53226
Applicant Contact Michelle Johnson
Correspondent
Ge Healthcare
9900 Innovation Dr.
Wauwatosa,  WI  53226
Correspondent Contact Michelle Johnson
Regulation Number880.5130
Classification Product Code
FMT  
Date Received06/16/2020
Decision Date 02/12/2021
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
Recalls CDRH Recalls
-
-