MODIFICATION TO: REPROCESSED OXIMAX PULSE OXIMETER SENSORS

MODIFICATION TO: REPROCESSED OXIMAX PULSE OXIMETER SENSORS is an FDA 510(k)-cleared medical device (K041127) manufactured by Sterilmed, 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 September 22, 2004. Regulation: 8.