
Hyperbaric Technologies, Inc.
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GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZER is an FDA 510(k)-cleared medical device (K001409) manufactured by Hyperbaric Technologies, 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 August 1, 2000. Regulation: 8.