The following data is part of a premarket notification filed by Snap40 Ltd with the FDA for Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package.
| Device ID | K182543 |
| 510k Number | K182543 |
| Device Name: | Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package |
| Classification | System, Network And Communication, Physiological Monitors |
| Applicant | snap40 Ltd 24 Forth Street Edinburgh, GB Eh1 3lh |
| Contact | Edwin Lindsay |
| Correspondent | Edwin Lindsay snap40 Ltd 24 Forth Street Edinburgh, GB Eh1 3lh |
| Product Code | MSX |
| Subsequent Product Code | BZQ |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DRG |
| Subsequent Product Code | FLL |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-17 |
| Decision Date | 2018-11-14 |
| Summary: | summary |