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510(k) K220820

Parky App by H2o Bilisim Yazilim — Product Code GYD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 2022
Date Received
March 21, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Tremor
Device Class
Class II
Regulation Number
882.1950
Review Panel
NE
Submission Type

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  • K063872 — KINESIA (April 6, 2007)
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