
Vital Signs, Inc.
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BREAS PV 10I CPAP SYSTEM, MODEL PV 10I is an FDA 510(k)-cleared medical device (K030985) manufactured by Vital Signs, 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 October 14, 2003. Regulation: 8.