SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER

SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER is an FDA 510(k)-cleared medical device (K001995) manufactured by Qrs Diagnostic, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 7, 2000. Regulation: 8.