LIFE PAK 12— 510(k) K973486

Name: FDA 510(k) clearance K973486
Creator: U.S. Food and Drug Administration
Published: 1998-01-09

Substantially Equivalent

Physio-Control Corp.

FDA 510(k) clearance K973486 for LIFE PAK 12, Substantially Equivalent on 1998-01-09. Applicant: Physio-Control Corp.. Device class: 3.

Clearance details

Applicant: Physio-Control Corp.
Product code: Code MKJ
Device class: Class 3
Regulation: 21 CFR 870.5310
Advisory panel: Cardiovascular
Date received: 1997-09-15
Decision date: 1998-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redmond, WA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Physio-Control Corp.

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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
K962359 — LIFEPAK 3001997-11-06
K955854 — LIFEPAK 5001996-11-04

Adverse events under product code MKJ

product code MKJ

Death: 961
Injury: 1,070
Malfunction: 90,719
Other: 8
Total: 92,758

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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