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 Plethysmograph, Impedance
510(k) Number K851415
Device Name BODY ANALYSIS SYSTEM (DEEMED SE 87/09/18)
Applicant
Medi-Sport Testing, Inc.
11919 NE Glisan
Portland,  OR  97220
Applicant Contact JAN GUSTAFSON
Correspondent
Medi-Sport Testing, Inc.
11919 NE Glisan
Portland,  OR  97220
Correspondent Contact JAN GUSTAFSON
Regulation Number870.2770
Classification Product Code
DSB  
Date Received04/09/1985
Decision Date 07/08/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-