
Biodex Medical Systems, Inc.
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ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336 is an FDA 510(k)-cleared medical device (K090296) manufactured by Biodex Medical Systems, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 18, 2009. Regulation: 8.