The following data is part of a premarket notification filed by Cardiocalm with the FDA for Cer-s.
| Device ID | K193177 |
| 510k Number | K193177 |
| Device Name: | CER-S |
| Classification | Electrocardiograph, Ambulatory, With Analysis Algorithm |
| Applicant | CardioCalm Corso Martiri Della Liberta, Nr. 40 Montichiari, IT 25018 |
| Contact | Fabio Badilini |
| Correspondent | Fabio Badilini CardioCalm Corso Martiri Della Liberta, Nr. 40 Montichiari, IT 25018 |
| Product Code | MLO |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-18 |
| Decision Date | 2020-08-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B972CCZ12050482030 | K193177 | 000 |