MODELS PB950 AND PB960 DATALOOP AND SPIROLOOP

MODELS PB950 AND PB960 DATALOOP AND SPIROLOOP is an FDA 510(k)-cleared medical device (K894667) manufactured by Pneumedics, 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 18, 1989. Regulation: 8.