
Polymap Wireless
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POLYTEL GMA, MODELS PWR-08-67, PWR-08-07, PWR-08-09 is an FDA 510(k)-cleared medical device (K091296) manufactured by Polymap Wireless. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 16, 2009. Regulation: 8.