
Shenzhen Delicate Electronics Co., Ltd.
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TRANSCRANIAL AND VASCULAR DOPPLER DIAGNOTIC ULTRASOUND TRANSDUCERS, MODEL EMS-9UA is an FDA 510(k)-cleared medical device (K092164) manufactured by Shenzhen Delicate Electronics Co., Ltd.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 12, 2010. Regulation: 8.