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 Automated External Defibrillators (Non-Wearable)
510(k) Number K984286
Device Name HEARTSTREAM ELECTRODE ADAPTER
Applicant
Hewlett-Packard Co.
2401 Fourth Ave., Suite 500
Seattle,  WA  98121
Applicant Contact WILLIAM D JORDAN
Correspondent
Hewlett-Packard Co.
2401 Fourth Ave., Suite 500
Seattle,  WA  98121
Correspondent Contact WILLIAM D JORDAN
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received12/01/1998
Decision Date 12/17/1998
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
-
-