
Hitachi Medical Systems America, Inc.
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ETG-100 OPTICAL ENCEPHALOGRAPHY SYSTEM is an FDA 510(k)-cleared medical device (K011320) manufactured by Hitachi Medical Systems America, 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 August 8, 2001. Regulation: 8.