The following data is part of a premarket notification filed by Medicalgorithmics S.a. with the FDA for Q Patch.
| Device ID | K210758 |
| 510k Number | K210758 |
| Device Name: | Q Patch |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | Medicalgorithmics S.A. Aleje Jerozolimskie 81 Warsaw, PL 02-001 |
| Contact | Marek Dziubinski |
| Correspondent | Agnieszka Romowicz Medicalgorithmics US Holding Corporation Corporation Service Company 251 Little Falls Drive Wilmington, DE 19808 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-15 |
| Decision Date | 2022-06-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05903021560162 | K210758 | 000 |
| 05903021560155 | K210758 | 000 |
| 05903021560124 | K210758 | 000 |