QUIK COMBO— 510(k) K943301

Name: FDA 510(k) clearance K943301
Creator: U.S. Food and Drug Administration
Published: 1995-02-03

Substantially Equivalent

Physio-Control Corp.

FDA 510(k) clearance K943301 for QUIK COMBO, Substantially Equivalent on 1995-02-03. Applicant: Physio-Control Corp.. Device class: 2.

Clearance details

Applicant: Physio-Control Corp.
Product code: Code DRX
Device class: Class 2
Regulation: 21 CFR 870.2360
Advisory panel: Cardiovascular
Date received: 1994-07-08
Decision date: 1995-02-03
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
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K983393 — LIFEPAK 500 BIPHASIC1999-05-05
K973486 — LIFE PAK 121998-01-09
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Adverse events under product code DRX

product code DRX

Death: 6
Injury: 476
Other: 2
Total: 484

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.