FDA 510(k), K092164, TRANSCRANIAL AND VASCULAR DOPPLER DIAGNOTIC ULTRASOUND TRANSDUCERS, MODEL EMS-9UA

FDA 510(k), K092164, TRANSCRANIAL AND VASCULAR DOPPLER DIAGNOTIC ULTRASOUND TRANSDUCERS, MODEL EMS-9UA

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510(K) Number: K092164
Device Name: TRANSCRANIAL AND VASCULAR DOPPLER DIAGNOTIC ULTRASOUND TRANSDUCERS, MODEL EMS-9UA
Manufacturer: WILLIAM STERN
Device Classification Name: Diagnostic Ultrasonic Transducer, Robotic
Regulation Number: OQQ
Classification Product Code: KXA
Date Received: 07/16/2009
Decision Date: 05/13/2010
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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