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 K042088
Device Name SAMARITAN PAD PAK DEFIBRILLATION ELECTRODE, MODEL SPP-301
Applicant
HEARTSINE TECHNOLOGIES, INC.
940 calle amanecer, suite e
san clemente,  CA  92673
Applicant Contact william j smirles
Correspondent
HEARTSINE TECHNOLOGIES, INC.
940 calle amanecer, suite e
san clemente,  CA  92673
Correspondent Contact william j smirles
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received08/03/2004
Decision Date 09/02/2004
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-