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Datex-Ohmeda, Inc.
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AMBULATORY BLOOD PRESSURE (ABP) 92506 REPORT MANAGEMENT SYSTEM (RMS), MODEL 92506 is an FDA 510(k)-cleared medical device (K031479) manufactured by Datex-Ohmeda, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 5, 2003. Regulation: 8.