Atlas FDA

731 Series Ventilators

FDA 510(k) clearance K162832 · decided 2017-08-02

Clearance details

K-number
K162832
Device name
731 Series Ventilators
Applicant
ZOLL Medical Corporation
Decision
Substantially Equivalent
Date received
2016-10-11
Decision date
2017-08-02
Days to decision
295 days
Clearance type
Traditional
Product code
CBK
Device class
2
Regulation number
868.5895
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Chelsmford, MA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
ZOLL 731 Ventilator (EMV+, AEV, Eagle II) - for MRI Compatible Devices - Operator's Guide recall (Z-2130-2024)ZOLL Medical Corporation2024-06-20

PMA approvals by this applicant

RecordFirmDate
OneStep CPR Complete Electrode (P160022/S049)ZOLL Medical Corporation2025-12-30
AED 3™ (P160015/S025)ZOLL Medical Corporation2025-12-18
X Series®; Propaq MD®; AED 3™ BLS; Zenix Professional Defibrillators (P160022/S046)ZOLL Medical Corporation2025-12-18
ZOLL Zenix Monitor/Defibrillator; ZOLL Zenix Multi-function Cable; ZOLL Zenix CPR Complete Electrodes; ZOLL OneStep Paci (P160022/S048)ZOLL Medical Corporation2025-12-09
ZOLL Zenix® Monitor/Defibrillator (P160022/S036)ZOLL Medical Corporation2025-09-29
CPR Uni-padz Electrode (P160022/S047)ZOLL Medical Corporation2025-09-22
CPR-D-padz Electrode (P160015/S026)ZOLL Medical Corporation2025-09-22
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