
Seratronics, Inc.
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DMS DATA MANAGEMENT SYSTEM/DRS-4 DIALYZER REPROCES is an FDA 510(k)-cleared medical device (K923529) manufactured by Seratronics, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 28, 1994. Regulation: 8.