The following data is part of a premarket notification filed by H2o Bilisim Yazilim with the FDA for Parky App.
| Device ID | K220820 |
| 510k Number | K220820 |
| Device Name: | Parky App |
| Classification | Transducer, Tremor |
| Applicant | H2O Bilisim Yazilim Mustafa Kemal Mah. 2119. Sok. No 3 Bilkent Cankaya, TR 06510 |
| Contact | Yagmur Selin Gulmus-Kolay |
| Correspondent | Yagmur Selin Gulmus-Kolay H2O Bilisim Yazilim Mustafa Kemal Mah. 2119. Sok. No 3 Bilkent Cankaya, TR 06510 |
| Product Code | GYD |
| Subsequent Product Code | ISD |
| Subsequent Product Code | NXQ |
| CFR Regulation Number | 882.1950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-21 |
| Decision Date | 2022-11-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860009869707 | K220820 | 000 |