510(k) Premarket Notification

• Device Classification Name: monitor, physiological, patient(with arrhythmia detection or alarms)
• 510(K) Number: K121367
• Model: ZOLL PROPAQ XM
• Device Name: ZOLL PROPAQ XM
• Applicant: ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford, MA 01824
• Contact: charles w kolifrath
• Regulation Number: 870.1025
• Classification Product Code: MHX
• Subsequent Product Codes: CCK DPS DQA DXN FLL
• Date Received: 05/07/2012
• Decision Date: 06/21/2012
• 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