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FDA 510(k), K142054, IMACOR ZURA EVO IMAGING SYSTEM
FDA 510(k), K142054, IMACOR ZURA EVO IMAGING SYSTEM
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510(K) Number: K142054
Device Name: IMACOR ZURA EVO IMAGING SYSTEM
Manufacturer: JAMES W MONROE
Device Classification Name: System, Imaging, Pulsed Echo, Ultrasonic
Regulation Number: IYO
Classification Product Code: KXA
Date Received: 07/29/2014
Decision Date: 09/29/2014
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: IMACOR ZURA EVO IMAGING SYSTEM
Manufacturer: JAMES W MONROE
Device Classification Name: System, Imaging, Pulsed Echo, Ultrasonic
Regulation Number: IYO
Classification Product Code: KXA
Date Received: 07/29/2014
Decision Date: 09/29/2014
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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