Patient Monitor, models LM-8, LM-10, LM-12 and LM-15

Patient Monitor, models LM-8, LM-10, LM-12 and LM-15 is an FDA 510(k)-cleared medical device (K221879) manufactured by Caf Medical Solutions, 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 9, 2022. Regulation: 8.