FDA 510(k), K180820, Tono Vue Non-Contact Tonometer
FDA 510(k), K180820, Tono Vue Non-Contact Tonometer
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510(K) Number: K180820
Device Name: Tono Vue Non-Contact Tonometer
Manufacturer: Crystalvue Medical Corporation
Device Classification Name: Tonometer, Ac-Powered
Regulation Number: 886.1930
Classification Product Code: HKX
Date Received: 03/29/2018
Decision Date: 12/14/2018
Regulation Medical Specialty: Ophthalmic
Device Name: Tono Vue Non-Contact Tonometer
Manufacturer: Crystalvue Medical Corporation
Device Classification Name: Tonometer, Ac-Powered
Regulation Number: 886.1930
Classification Product Code: HKX
Date Received: 03/29/2018
Decision Date: 12/14/2018
Regulation Medical Specialty: Ophthalmic
- 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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