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 K123881
FOIA Releasable 510(k) K123881
Device Name HEARTSINE SAMARITAN PAD 350P
Applicant
Heartsine Technologies, Inc.
203 Airport Rd. W.
Belfast
Northern,  IE BT3 9ED
Applicant Contact JAMES MCGUINNESS
Correspondent
Heartsine Technologies, Inc.
203 Airport Rd. W.
Belfast
Northern,  IE BT3 9ED
Correspondent Contact JAMES MCGUINNESS
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received12/17/2012
Decision Date 07/11/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-