
Air-Shields, Inc.
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MODELS C500/C550 ISOLETE(R) INFANT INCUBATOR is an FDA 510(k)-cleared medical device (K914864) manufactured by Air-Shields, Inc.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 12, 1992. Regulation: 8.

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