The following data is part of a premarket notification filed by Cardiocalm Srl with the FDA for Cer-s.
| Device ID | K213861 |
| 510k Number | K213861 |
| Device Name: | CER-S |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | CardioCalm Srl Via Martiri Della Liberta, Nr. 40 Montichiari, IT 25018 |
| Contact | Fabio Badilini |
| Correspondent | Fabio Badilini CardioCalm Srl Via Martiri Della Liberta, Nr. 40 Montichiari, IT 25018 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-10 |
| Decision Date | 2022-04-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B972CCZ12050482050 | K213861 | 000 |