
Invacare Corp.
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INVACARE PASSOVER HUMIDIFIER MODEL ISP9700 is an FDA 510(k)-cleared medical device (K003561) manufactured by Invacare Corp.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 16, 2001. Regulation: 8.