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
510(k) Number K961401
Device Name HP CATHSTATION - MODEL M1264B
Applicant
HEWLETT-PACKARD CO.
3000 MINUTEMAN RD.
ANDOVER,  MA  01810 -1085
Applicant Contact ROB BUTLER
Correspondent
HEWLETT-PACKARD CO.
3000 MINUTEMAN RD.
ANDOVER,  MA  01810 -1085
Correspondent Contact ROB BUTLER
Regulation Number870.2340
Classification Product Code
DPS  
Date Received04/11/1996
Decision Date 10/08/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-