FDA 510(k), K050812, 90XL INSTRUMENTATION SYSTEM

FDA 510(k), K050812, 90XL INSTRUMENTATION SYSTEM

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510(K) Number: K050812
Device Name: 90XL INSTRUMENTATION SYSTEM
Manufacturer: TODD ROMERO
Device Classification Name: Meter, Conductivity, Non-Remote
Regulation Number: FIZ
Classification Product Code: KXA
Date Received: 03/31/2005
Decision Date: 05/05/2005
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
  • 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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