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 Bed, Patient Rotation, Powered
510(k) Number K905390
Device Name KUDO (POWERED ROTATION BED)
Applicant
Kinetic Concepts, Inc.
P.O. Box 8588
San Antonio,  TX  78208
Applicant Contact WEHRMEYER, JR
Correspondent
Kinetic Concepts, Inc.
P.O. Box 8588
San Antonio,  TX  78208
Correspondent Contact WEHRMEYER, JR
Regulation Number890.5225
Classification Product Code
IKZ  
Date Received11/30/1990
Decision Date 01/08/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-