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FDA 510(k), K150221, EPX-4440HD and EPX-4400HD with FICE
FDA 510(k), K150221, EPX-4440HD and EPX-4400HD with FICE
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510(K) Number: K150221
Device Name: EPX-4440HD and EPX-4400HD with FICE
Manufacturer: MARY MOORE
Device Classification Name: Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Regulation Number: FET
Classification Product Code: KXA
Date Received: 01/30/2015
Decision Date: 10/01/2015
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: EPX-4440HD and EPX-4400HD with FICE
Manufacturer: MARY MOORE
Device Classification Name: Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Regulation Number: FET
Classification Product Code: KXA
Date Received: 01/30/2015
Decision Date: 10/01/2015
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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