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 K110978
Device Name ONESTEP PEDIATRIC MFE'S
Applicant
ZOLL Medical Corporation
525 Narragansett Park Dr.
Pawtucket,  RI  02861
Applicant Contact ROBERT MORSE
Correspondent
ZOLL Medical Corporation
525 Narragansett Park Dr.
Pawtucket,  RI  02861
Correspondent Contact ROBERT MORSE
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received04/07/2011
Decision Date 05/13/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-