The following data is part of a premarket notification filed by Bittium Biosignals Ltd. with the FDA for Faros Mobile.
| Device ID | K182030 |
| 510k Number | K182030 |
| Device Name: | Faros Mobile |
| Classification | Electrocardiograph, Ambulatory, With Analysis Algorithm |
| Applicant | Bittium Biosignals Ltd. Pioneerinkatu 6 Kuopio, FI Fi-70800 |
| Contact | Taneli Vaaraniemi |
| Correspondent | Taneli Vaaraniemi Bittium Biosignals Ltd. Pioneerinkatu 6 Kuopio, FI Fi-70800 |
| Product Code | MLO |
| Subsequent Product Code | DSI |
| Subsequent Product Code | DXH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-30 |
| Decision Date | 2018-11-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06430035220366 | K182030 | 000 |
| 06430035220328 | K182030 | 000 |