SPECTRUM 2 REUSABLE FULL FACE MASK, MODEL 1004884 AND 1004876

SPECTRUM 2 REUSABLE FULL FACE MASK, MODEL 1004884 AND 1004876 is an FDA 510(k)-cleared medical device (K002465) manufactured by Respironics, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 7, 2000. Regulation: 8.