510(k) Premarket Notification

• Device Classification Name: automated external defibrillators (non-wearable)
• 510(K) Number: K120907
• Model: ZOLL R SERIES
• Device Name: ZOLL R SERIES
• Applicant: ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS; 269 mill road; chelmsford, MA 01824 4105
• Contact: charles w kolifrath
• Regulation Number: 870.5310
• Classification Product Code: MKJ
• Subsequent Product Codes: CCK DQA DRO DRT DXN LDD LIX
• Date Received: 03/26/2012
• Decision Date: 09/25/2012
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: Cardiovascular
• Review Advisory Committee: Cardiovascular
• summary: summary
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No