• 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, Flotation Therapy, Powered
510(k) Number K901295
Device Name PULMONAIR 40 PATIENT MANAGEMENT SYSTEM
Applicant
The Medical Group, Inc.
P.O. Box 5067
Buena Park,  CA  90620
Applicant Contact DIANE KOMOS
Correspondent
The Medical Group, Inc.
P.O. Box 5067
Buena Park,  CA  90620
Correspondent Contact DIANE KOMOS
Regulation Number890.5170
Classification Product Code
IOQ  
Date Received03/20/1990
Decision Date 03/30/1990
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
-
-