XR MODEL H PHYSIOLOGICAL MONITOR & RECORDING SYS.

XR MODEL H PHYSIOLOGICAL MONITOR & RECORDING SYS. is an FDA 510(k)-cleared medical device (K901514) manufactured by Ppg Industries, 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 15, 1990. Regulation: 8.