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 K031387
Device Name ISOLETTE INFANT INCUBATOR, MODEL C2000E
Applicant
Hill-Rom Manufacturing, Inc.
330 Jacksonville Rd.
Hatboro,  PA  19040
Applicant Contact MONICA FERRANTE
Correspondent
Hill-Rom Manufacturing, Inc.
330 Jacksonville Rd.
Hatboro,  PA  19040
Correspondent Contact MONICA FERRANTE
Regulation Number880.5400
Classification Product Code
FMZ  
Subsequent Product Code
FPL  
Date Received05/02/2003
Decision Date 08/01/2003
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
-
-