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FDA 510(k)

Parky App

K-Number: K220820 · 2022-11-17

ApplicantH2o Bilisim Yazilim
Decision Date2022-11-17
Product CodeGYD
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Parky App is the device name listed in this FDA 510(k) record. The listed applicant is H2o Bilisim Yazilim. It received FDA 510(k) clearance on 2022-11-17 under 510(k) number K220820. The device is classified under product code GYD. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Parky App?

Parky App is a medical device that received FDA 510(k) clearance on 2022-11-17. The listed applicant is H2o Bilisim Yazilim. The 510(k) number is K220820.

When did Parky App receive FDA 510(k) clearance?

Parky App received FDA 510(k) clearance on 2022-11-17, under 510(k) number K220820.

Who is the listed applicant for Parky App?

The FDA 510(k) record lists H2o Bilisim Yazilim as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Parky App?

The FDA product code for Parky App is GYD.

Related Devices (Code: GYD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Monitor by Empatica; Care PortalEmpatica S.r.l.K253055Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple Watch (“SMPDTDAW”)Nordic Kinetics ABK250153Neu PlatformNeuhealth Digital , Ltd.K221772NeuroRPMNew Touch Digital, Inc.K213519Rune Labs Tremor Transducer SystemRune Labs, Inc.K211887Personal Kinetigraph (PKG) System Gen 2 PlusGkc Manufacturing Pty, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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