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 Stethoscope, Electronic
510(k) Number K051450
Device Name EXTENDED MEASUREMENTS SYSTEM
Applicant
Inovise Medical, Inc.
10565 SW Nimbus Ave.
Suite 100
Portland,  OR  97223
Applicant Contact STEVE C HESLER
Correspondent
Inovise Medical, Inc.
10565 SW Nimbus Ave.
Suite 100
Portland,  OR  97223
Correspondent Contact STEVE C HESLER
Regulation Number870.1875
Classification Product Code
DQD  
Date Received06/02/2005
Decision Date 11/10/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-