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FDA 510(k), K141833, STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PATIENT TRACKER, TRACER POINTER, TOUCH-N-GO POINTER, NAVIGATION
FDA 510(k), K141833, STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PATIENT TRACKER, TRACER POINTER, TOUCH-N-GO POINTER, NAVIGATION
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510(K) Number: K141833
Device Name: STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PATIENT TRACKER, TRACER POINTER, TOUCH-N-GO POINTER, NAVIGATION
Manufacturer: MEDTRONIC NAVIGATION, INC.
Device Classification Name: neurological stereotaxic instrument
Regulation Number: 882.4560
Classification Product Code: HAW
Date Received: 07/07/2014
Decision Date: 03/25/2015
Regulation Medical Specialty: Neurology
Device Name: STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PATIENT TRACKER, TRACER POINTER, TOUCH-N-GO POINTER, NAVIGATION
Manufacturer: MEDTRONIC NAVIGATION, INC.
Device Classification Name: neurological stereotaxic instrument
Regulation Number: 882.4560
Classification Product Code: HAW
Date Received: 07/07/2014
Decision Date: 03/25/2015
Regulation Medical Specialty: Neurology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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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