CPR EZY MASK AND PAD— 510(k) K003937

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..

Clearance details

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

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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.