PMA P160022S013

Device: ZOLL X Series, Propaq MD, and X Series Advanced
Applicant: ZOLL Medical Corporation
Product code: MKJ
Decision date: 2020-08-25
Generic name: Automated external defibrillators (non-wearable)
Approval order statement: Approval for a software update to Version 02.34 (including implementation of Real Bag-Valve Mask Help Ventilation Feedback (Real BVM Help), a traumatic brain injury dashboard (TBI Dashboard), and the ability to retry to 12-Lead electrocardiograph report transmission up to five times), the addition of the AccuVent Sensor System accessory, and the rebranding of the device from X Series to X Series Advanced.

Current openFDA PMA Record#

Device: ZOLL X Series, Propaq MD, and X Series Advanced
Applicant: ZOLL Medical Corporation
PMA number: P160022
Supplement: S013
Product code: MKJ
Generic name: Automated external defibrillators (non-wearable)
Decision date: 2020-08-25
Decision code: APPR
Date received: 2019-09-03
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a software update to Version 02.34 (including implementation of Real Bag-Valve Mask Help Ventilation Feedback (Real BVM Help), a traumatic brain injury dashboard (TBI Dashboard), and the ability to retry to 12-Lead electrocardiograph report transmission up to five times), the addition of the AccuVent Sensor System accessory, and the rebranding of the device from X Series to X Series Advanced.