CPR EZY MASK AND PAD— 510(k) K003937

Name: FDA 510(k) clearance K003937
Creator: U.S. Food and Drug Administration
Published: 2001-06-06

Substantially Equivalent

Medteq Innovations Pty, Ltd.

FDA 510(k) clearance K003937 for CPR EZY MASK AND PAD, Substantially Equivalent on 2001-06-06. Applicant: Medteq Innovations Pty, Ltd.. Device class: 2.

Clearance details

Applicant: Medteq Innovations Pty, Ltd.
Product code: Code LIX
Device class: Class 2
Regulation: 21 CFR 870.5210
Advisory panel: Cardiovascular
Date received: 2000-12-20
Decision date: 2001-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LIX

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K201581 — CPR BAND2021-03-06
K183348 — Reusable Silicone Cover CPRmeter 22018-12-17
K173886 — CPRmeter 2 CPR Feedback Device2018-03-23
K151702 — Reusable Full Silicone Cover2015-08-13
K123248 — CPR RSQ ASSIST2013-12-10

Adverse events under product code LIX

product code LIX

Other: 2
Total: 2

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.