LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER, AND LIFEPAK 11 CARDIAC MONITOR— 510(k) K945511

Name: FDA 510(k) clearance K945511
Creator: U.S. Food and Drug Administration
Published: 1995-09-26

Substantially Equivalent

Physio-Control Corp.

FDA 510(k) clearance K945511 for LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER, AND LIFEPAK 11 CARDIAC MONITOR, Substantially Equivalent on 1995-09-26. Applicant: Physio-Control Corp.. Device class: 2.

Clearance details

Applicant: Physio-Control Corp.
Product code: Code MPE
Device class: Class 2
Regulation: 21 CFR 870.5550
Advisory panel: Cardiovascular
Date received: 1994-11-09
Decision date: 1995-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redmond, WA, US

Download summary PDF View on FDA.gov ↗

More clearances from Physio-Control Corp.

view all

K991910 — LIFEPAK 12 BIPHASIC1999-09-03
K990338 — NIBP AND CO2 OPTIONS FOR THE PHYSIO-CONTROL LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM1999-09-01
K983393 — LIFEPAK 500 BIPHASIC1999-05-05
K973486 — LIFE PAK 121998-01-09
K962359 — LIFEPAK 3001997-11-06

Data sourced from openFDA. This site is unofficial and independent of the FDA.