Parky App

Transducer, Tremor

H2O Bilisim Yazilim

The following data is part of a premarket notification filed by H2o Bilisim Yazilim with the FDA for Parky App.

Pre-market Notification Details

Device IDK220820
510k NumberK220820
Device Name:Parky App
ClassificationTransducer, Tremor
Applicant H2O Bilisim Yazilim Mustafa Kemal Mah. 2119. Sok. No 3 Bilkent Cankaya,  TR 06510
ContactYagmur Selin Gulmus-Kolay
CorrespondentYagmur Selin Gulmus-Kolay
H2O Bilisim Yazilim Mustafa Kemal Mah. 2119. Sok. No 3 Bilkent Cankaya,  TR 06510
Product CodeGYD  
Subsequent Product CodeISD
Subsequent Product CodeNXQ
CFR Regulation Number882.1950 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-21
Decision Date2022-11-17

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