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FDA 510(k)

LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER, AND LIFEPAK 11 CARDIAC MONITOR

K-Number: K945511 · 1995-09-26

ApplicantPhysio-Control Corp.
Decision Date1995-09-26
Product CodeMPE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER, AND LIFEPAK 11 CARDIAC MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Physio-Control Corp.. It received FDA 510(k) clearance on 1995-09-26 under 510(k) number K945511. The device is classified under product code MPE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER, AND LIFEPAK 11 CARDIAC MONITOR?

LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER, AND LIFEPAK 11 CARDIAC MONITOR is a medical device that received FDA 510(k) clearance on 1995-09-26. The listed applicant is Physio-Control Corp.. The 510(k) number is K945511.

When did LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER, AND LIFEPAK 11 CARDIAC MONITOR receive FDA 510(k) clearance?

LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER, AND LIFEPAK 11 CARDIAC MONITOR received FDA 510(k) clearance on 1995-09-26, under 510(k) number K945511.

Who is the listed applicant for LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER, AND LIFEPAK 11 CARDIAC MONITOR?

The FDA 510(k) record lists Physio-Control Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER, AND LIFEPAK 11 CARDIAC MONITOR?

The FDA product code for LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER, AND LIFEPAK 11 CARDIAC MONITOR is MPE.

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Other records listing Physio-Control Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K991910LIFEPAK 12 BIPHASICK990338NIBP AND CO2 OPTIONS FOR THE PHYSIO-CONTROL LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEMK983393LIFEPAK 500 BIPHASICK973486LIFE PAK 12K962359LIFEPAK 300K955854LIFEPAK 500

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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