
Elekon Industries U.S.A., Inc.
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FLEXI-STAT REUSABLE FINGER CLIP SPO2 SENSORS (NELLCOR-COMPATIBLE),(BCI-COMPATIBLE), (DATEX-COMPATIBLE) is an FDA 510(k)-cleared medical device (K041647) manufactured by Elekon Industries U.S.A., 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 1, 2004. Regulation: 8.