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 Transport
510(k) Number K893624
Device Name PREEMICARE MODEL 2500 TRANSPORT WARMER
Applicant
Preemicare Corp.
3300 Walnut Bend Ln.
Houston,  TX  77042
Applicant Contact CHARLES BOYD
Correspondent
Preemicare Corp.
3300 Walnut Bend Ln.
Houston,  TX  77042
Correspondent Contact CHARLES BOYD
Regulation Number880.5410
Classification Product Code
FPL  
Date Received05/11/1989
Decision Date 09/27/1989
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
-
-