
Suntech Medical Instruments, Inc.
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PRESSURE TRAK, MODEL 222-B is an FDA 510(k)-cleared medical device (K010622) manufactured by Suntech Medical 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 March 28, 2001. Regulation: 8.