
Standard Imaging, Inc.
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HDR 1000 PLUS WELL CHAMBER, MODEL 90008 is an FDA 510(k)-cleared medical device (K060532) manufactured by Standard Imaging, 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 April 10, 2006. Regulation: 8.