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FDA 510(k), K162067, VX130 Ophthalmic Diagnostic Device
FDA 510(k), K162067, VX130 Ophthalmic Diagnostic Device
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510(K) Number: K162067
Device Name: VX130 Ophthalmic Diagnostic Device
Manufacturer: ISABELLE DURAND
Device Classification Name: Tonometer, Ac-Powered
Regulation Number: HKX
Classification Product Code: KXA
Date Received: 07/26/2016
Decision Date: 04/24/2017
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ophthalmic
Device Name: VX130 Ophthalmic Diagnostic Device
Manufacturer: ISABELLE DURAND
Device Classification Name: Tonometer, Ac-Powered
Regulation Number: HKX
Classification Product Code: KXA
Date Received: 07/26/2016
Decision Date: 04/24/2017
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ophthalmic
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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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