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Zoll OneStep CPR Cable, R Series OneStep Pacing Cable, X Series OneStep Cable, X Series/Propaq MD Multifunction Therapy

FDA premarket approval P160022/S015 · decided 2023-06-21

Approval details

PMA number
P160022
Supplement
S015
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Trade name
Zoll OneStep CPR Cable, R Series OneStep Pacing Cable, X Series OneStep Cable, X Series/Propaq MD Multifunction Therapy
Generic name
Automated external defibrillators (non-wearable)
Applicant
ZOLL Medical Corporation
Date received
2020-01-28
Decision date
2023-06-21
Days to decision
1240 days
Decision code
APPR
Product code
MKJ
Advisory committee
Cardiovascular
Expedited review
No
Location
Chelsmford, MA
Statement
Approval for the following Zoll automated external defibrillator (AED) accessories: 1) Zoll OneStep CPR Cable;2) R Series OneStep Pacing Cable;3) X Series OneStep Cable;4) X Series/Propaq MD Multifunction Therapy Cable;5) OneStep CPR Complete Electrodes;6) OneStep CPR Complete Adult-Child Electrodes;7) OneStep Basic Electrodes;8) OneStep Pacing Electrodes;9) OneStep Pediatric Electrodes;10) OneStep Pediatric CPR Electrodes;11) OneStep CPR II Electrodes;12) OneStep CPR A/A (Anterior/Anterior) Ele

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510(k) clearances by this applicant

RecordFirmDate
731 Series Ventilator (K233486)ZOLL Medical Corporation2024-12-13
ZOLL Propaq M (K202375)ZOLL Medical Corporation2021-03-09
ZOLL Propaq M (K180482)ZOLL Medical Corporation2018-11-30
Power Infuser (K172653)ZOLL Medical Corporation2018-07-18
731 Series Ventilators (K162832)ZOLL Medical Corporation2017-08-02
Model 330 Multifunction Aspirator (K170533)ZOLL Medical Corporation2017-04-18
ZOLL X Series (K142915)ZOLL Medical Corporation2014-12-03
ZOLL X SERIES (K141774)ZOLL Medical Corporation2014-11-19