The following data is part of a premarket notification filed by Medicalgorithmics S.a. with the FDA for Deeprhythmai.
| Device ID | K210822 |
| 510k Number | K210822 |
| Device Name: | DeepRhythmAI |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | Medicalgorithmics S.A. Aleje Jerozolimskie 81 Warsaw, PL 02-001 |
| Contact | Marek Dziubinski |
| Correspondent | Agnieszka Romowicz Medicalgorithmics US Holding Corporation 2711 Centerville Road, Suite 400 Wilmington, DE 19808 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-19 |
| Decision Date | 2022-07-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05903021560131 | K210822 | 000 |