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 K992197
Device Name MODIFICATION TO ZYMED HOLTER 2000
Applicant
ZYMED MEDICAL INSTRUMENTATION
20 NORTH AVIADOR ST.
CAMARILLO,  CA  93010
Applicant Contact GRETEL LUMLEY
Correspondent
ZYMED MEDICAL INSTRUMENTATION
20 NORTH AVIADOR ST.
CAMARILLO,  CA  93010
Correspondent Contact GRETEL LUMLEY
Regulation Number870.2800
Classification Product Code
MLO  
Date Received06/30/1999
Decision Date 07/28/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-