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 K932417
Device Name FERNO WASHINGTON INCUBATOR TRANSPORTER, MOD. 35-IT
Applicant
Ferno-Washington, Inc.
70 Weil Way
Wilmington,  OH  45177
Applicant Contact RENEE WALZ
Correspondent
Ferno-Washington, Inc.
70 Weil Way
Wilmington,  OH  45177
Correspondent Contact RENEE WALZ
Regulation Number880.5410
Classification Product Code
FPL  
Date Received05/18/1993
Decision Date 09/09/1993
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
-
-