INDEX 2E, INDEX 2F, INDEX 2EF, CARDIOSAT 100E, CARDIOSAT 100F, CARDIOSAT 100EF

INDEX 2E, INDEX 2F, INDEX 2EF, CARDIOSAT 100E, CARDIOSAT 100F, CARDIOSAT 100EF is an FDA 510(k)-cleared medical device (K971273) manufactured by Bio-Tek Instruments, 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 October 7, 1997. Regulation: 8.