DATEX-ENGSTROM LIGHT MONITOR MODELS F-LM1, F-LMP1

DATEX-ENGSTROM LIGHT MONITOR MODELS F-LM1, F-LMP1 is an FDA 510(k)-cleared medical device (K981378) manufactured by Datex-Engstrom, 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 November 2, 1998. Regulation: 8.