PMA P160026S031

Device: LIFEPAK Automated External Defibrillator (AED)
Applicant: Physio-Control, Inc.
PMA number: P160026
Supplement: S031
Product code: MKJ
Decision date: 2022-07-28
Generic name: Automated external defibrillators (non-wearable)
Approval order statement: Approval for design changes to support integration of the nanoMediCO2 capnography (EtCO2) module and software changes intended to mitigate an unexpected anomaly related to the Service LED function of the LIFEPAK 15 Monitor/Defibrillator device.

Current openFDA PMA Record#

Device: LIFEPAK Automated External Defibrillator (AED)
Applicant: Physio-Control, Inc.
PMA number: P160026
Supplement: S031
Product code: MKJ
Generic name: Automated external defibrillators (non-wearable)
Decision date: 2022-07-28
Decision code: APPR
Date received: 2022-05-13
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for design changes to support integration of the nanoMediCO2 capnography (EtCO2) module and software changes intended to mitigate an unexpected anomaly related to the Service LED function of the LIFEPAK 15 Monitor/Defibrillator device.