
Ge Medical Systems Information Technologies, Inc.
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Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P is an FDA 510(k)-cleared medical device (K242562) manufactured by Ge Medical Systems Information Technologies, 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 July 8, 2025. Regulation: 8.

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