PMA P160026

Device: LIFEPAK® 15 monitor/defibrillator
Applicant: Physio-Control, Inc.
PMA number: P160026
Supplement: S037
Product code: MKJ
Decision date: 2026-05-06
Generic name: Automated external defibrillators (non-wearable)
Approval order statement: Approval for design changes to replace obsolete hardware sub-components in the End Tidal CO2 (EtCO2) module and to update materials and remove an electrical component in the Printer module of the LIFEPAK® 15 monitor/defibrillator.

Current openFDA PMA Record#

Device: LIFEPAK® 15 monitor/defibrillator
Applicant: Physio-Control, Inc.
PMA number: P160026
Supplement: S067
Product code: MKJ
Generic name: Automated external defibrillators (non-wearable)
Decision date: 2026-05-06
Decision code: APPR
Date received: 2026-02-09
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for design changes to replace obsolete hardware sub-components in the End Tidal CO2 (EtCO2) module and to update materials and remove an electrical component in the Printer module of the LIFEPAK® 15 monitor/defibrillator.