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FDA 510(k), K170551, ImPACT Quick Test
FDA 510(k), K170551, ImPACT Quick Test
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510(K) Number: K170551
Device Name: ImPACT Quick Test
Manufacturer: Michael Zagorski
Device Classification Name: Computerized Cognitive Assessment Aid For Concussion
Regulation Number: POM
Classification Product Code: KXA
Date Received: 02/24/2017
Decision Date: 06/21/2017
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
Device Name: ImPACT Quick Test
Manufacturer: Michael Zagorski
Device Classification Name: Computerized Cognitive Assessment Aid For Concussion
Regulation Number: POM
Classification Product Code: KXA
Date Received: 02/24/2017
Decision Date: 06/21/2017
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
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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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