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 System, Network And Communication, Physiological Monitors
510(k) Number K121865
Device Name ZOLL RESCUENET 12-LEAD
Applicant
ZOLL Medical Corporation
269 Mill Rd.
Chelsmford,  MA  01824
Applicant Contact CHARLES W KOLIFRATH
Correspondent
ZOLL Medical Corporation
269 Mill Rd.
Chelsmford,  MA  01824
Correspondent Contact CHARLES W KOLIFRATH
Regulation Number870.2300
Classification Product Code
MSX  
Date Received06/26/2012
Decision Date 11/20/2012
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
-
-