Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P

Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P is an FDA 510(k)-cleared medical device (K213490) 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 March 31, 2022. Regulation: 8.