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 Electrocardiograph, Ambulatory, With Analysis Algorithm
510(k) Number K031466
Device Name IQMARK DIGITAL HOLTER
Applicant
Brentwood Medical Technology Corp.
3300 Fujita St.
Torrance,  CA  90505
Applicant Contact RUOMEI ZHANG
Correspondent
Brentwood Medical Technology Corp.
3300 Fujita St.
Torrance,  CA  90505
Correspondent Contact RUOMEI ZHANG
Regulation Number870.2800
Classification Product Code
MLO  
Date Received05/08/2003
Decision Date 06/11/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-