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FDA 510(k), K220820, Parky App
FDA 510(k), K220820, Parky App
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510(K) Number: K220820
Device Name: Parky App
Manufacturer: Yagmur Selin Gulmus-Kolay
Device Classification Name: Transducer, Tremor
Regulation Number: GYD
Classification Product Code: 03/21/2022
Date Received: 11/17/2022
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
Device Name: Parky App
Manufacturer: Yagmur Selin Gulmus-Kolay
Device Classification Name: Transducer, Tremor
Regulation Number: GYD
Classification Product Code: 03/21/2022
Date Received: 11/17/2022
Decision Date: Substantially Equivalent (SESE)
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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