The following data is part of a premarket notification filed by Cardiologs Technologies with the FDA for Cardiologs Holter Platform.
| Device ID | K212112 |
| 510k Number | K212112 |
| Device Name: | Cardiologs Holter Platform |
| Classification | Electrocardiograph |
| Applicant | Cardiologs Technologies 136 Rue Saint Denis Paris, FR 75002 |
| Contact | Arezou Azar |
| Correspondent | Arezou Azar Cardiologs Technologies 136 Rue Saint Denis Paris, FR 75002 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-06 |
| Decision Date | 2021-11-18 |