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 Bath, Hydro-Massage
510(k) Number K001079
Device Name RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO
Applicant
Arjo, Inc.
50 N. Gary Ave., Suite A
Roselle,  IL  60172
Applicant Contact DAVID INSCO
Correspondent
Arjo, Inc.
50 N. Gary Ave., Suite A
Roselle,  IL  60172
Correspondent Contact DAVID INSCO
Regulation Number890.5100
Classification Product Code
ILJ  
Date Received04/04/2000
Decision Date 05/01/2000
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
-
-