
Philips Medical Systems (Cleveland), Inc.
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BLOOD OXYGENATION LEVEL DEPENDENT (BOLD) OPTION is an FDA 510(k)-cleared medical device (K010691) manufactured by Philips Medical Systems (Cleveland), 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 May 7, 2001. Regulation: 8.