ZOLL R SERIES

Automated External Defibrillators (non-wearable)

ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS

The following data is part of a premarket notification filed by Zoll Medical Corporation, World Wide Headquarters with the FDA for Zoll R Series.

Pre-market Notification Details

• Device ID: K120907
• 510k Number: K120907
• Device Name: ZOLL R SERIES
• Classification: Automated External Defibrillators (non-wearable)
• Applicant: ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS 269 MILL ROAD Chelmsford, MA 01824 -4105
• Contact: Charles W Kolifrath
• Correspondent: Charles W Kolifrath; ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS 269 MILL ROAD Chelmsford, MA 01824 -4105
• Product Code: MKJ
• Subsequent Product Code: CCK
• Subsequent Product Code: DQA
• Subsequent Product Code: DRO
• Subsequent Product Code: DRT
• Subsequent Product Code: DXN
• Subsequent Product Code: LDD
• Subsequent Product Code: LIX
• CFR Regulation Number: 870.5310 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-03-26
• Decision Date: 2012-09-25
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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