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FDA 510(k), K172735, WR19 System
FDA 510(k), K172735, WR19 System
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510(K) Number: K172735
Device Name: WR19 System
Manufacturer: Zeto, Inc.
Device Classification Name: Full-Montage Standard Electroencephalograph
Regulation Number: 882.1400
Classification Product Code: GWQ
Date Received: 09/11/2017
Decision Date: 04/17/2018
Regulation Medical Specialty: Neurology
Device Name: WR19 System
Manufacturer: Zeto, Inc.
Device Classification Name: Full-Montage Standard Electroencephalograph
Regulation Number: 882.1400
Classification Product Code: GWQ
Date Received: 09/11/2017
Decision Date: 04/17/2018
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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