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 K190494
Device Name Infant Incubator
Applicant
Ningbo David Medical Device Co.,Ltd
No.2, Keyuan Road, Shipu Technology Park,
Xiangshan
Ningbo,  CN 315731
Applicant Contact Lin Dingyu
Correspondent
Ningbo David Medical Device Co.,Ltd
No.2, Keyuan Road, Shipu Technology Park,
Xiangshan
Ningbo,  CN 315731
Correspondent Contact Lin Dingyu
Regulation Number880.5400
Classification Product Code
FMZ  
Subsequent Product Code
FMT  
Date Received02/28/2019
Decision Date 11/25/2019
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
-
-