VITALMAX 500 PULSE OXIMETER W/TEMP. AND RESPIRA.

VITALMAX 500 PULSE OXIMETER W/TEMP. AND RESPIRA. is an FDA 510(k)-cleared medical device (K901066) manufactured by Pace Tech, 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 27, 1990. Regulation: 8.