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 K090989
Device Name ZOLL R SERIES WITH NIBP AND ETCO2 OPTIONS, ZOLL R SERIES
Applicant
Zoll Medical Corp
269 Mill Rd.
Chelsmford,  MA  01824
Applicant Contact CHARLES W KOLIFRATH
Correspondent
Zoll Medical Corp
269 Mill Rd.
Chelsmford,  MA  01824
Correspondent Contact CHARLES W KOLIFRATH
Regulation Number870.5310
Classification Product Code
MKJ  
Subsequent Product Codes
CCK   DQA   DRM   DRO   DRT  
DXN   LDD  
Date Received04/07/2009
Decision Date 09/23/2009
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
-
-