FDA 510(k), K133444, STEALTHSTATION S7 / I7 / FUSION NAVIGATION SYSTEMS, AXIEM NAVIGATION SYSTEM

FDA 510(k), K133444, STEALTHSTATION S7 / I7 / FUSION NAVIGATION SYSTEMS, AXIEM NAVIGATION SYSTEM

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510(K) Number: K133444
Device Name: STEALTHSTATION S7 / I7 / FUSION NAVIGATION SYSTEMS, AXIEM NAVIGATION SYSTEM
Manufacturer: KAYE WAITE
Device Classification Name: Neurological Stereotaxic Instrument
Regulation Number: HAW
Classification Product Code: KXA
Date Received: 11/12/2013
Decision Date: 07/25/2014
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
  • 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. IMPORTANT: The FDA FOIA office operations are currently suspended. We are happy to make the request but do not know when we will receive a response. Learn more about Fast-Track Requests here.

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