
Vivometrics, Inc.
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LIFESHIRT SYSTEM WITH VIVOLOGIC ANALYSIS SOFTWARE is an FDA 510(k)-cleared medical device (K011903) manufactured by Vivometrics, 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 April 11, 2002. Regulation: 8.