
Medteq Innovations Pty, Ltd.
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CPR EZY MASK AND PAD is an FDA 510(k)-cleared medical device (K003937) manufactured by Medteq Innovations Pty, Ltd.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 5, 2001. Regulation: 8.