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 Transmitters And Receivers, Electrocardiograph, Telephone
510(k) Number K980624
Device Name CARDIOSTATION
Applicant
UNIVERSAL MEDICAL, INC.
1608 WALNUT ST.
SIXTH FLOOR
PHILADELPHIA,  PA  19103
Applicant Contact DOUGLAS M LURIO
Correspondent
UNIVERSAL MEDICAL, INC.
1608 WALNUT ST.
SIXTH FLOOR
PHILADELPHIA,  PA  19103
Correspondent Contact DOUGLAS M LURIO
Regulation Number870.2920
Classification Product Code
DXH  
Date Received02/18/1998
Decision Date 05/11/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-