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 Incubator, Neonatal
510(k) Number K251619
Device Name Babyleo TN500
Applicant
Drägerwerk AG & Co KGaA
Moislinger Allee 53-55
Schleswig-Holstein
Luebeck,  DE 23542
Applicant Contact Lyubov Lange
Correspondent
Drägerwerk AG & Co KGaA
Moislinger Allee 53-55
Schleswig-Holstein
Luebeck,  DE 23542
Correspondent Contact Lyubov Lange
Regulation Number880.5400
Classification Product Code
FMZ  
Subsequent Product Code
FMT  
Date Received05/27/2025
Decision Date 02/13/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-