The following data is part of a premarket notification filed by Current Health Ltd with the FDA for Wearable Device, Home Package In Carry Case With Homehub, Home Package In Carry Case Without Homehub.
| Device ID | K190073 |
| 510k Number | K190073 |
| Device Name: | Wearable Device, Home Package In Carry Case With Homehub, Home Package In Carry Case Without Homehub |
| Classification | System, Network And Communication, Physiological Monitors |
| Applicant | Current Health Ltd Playfair House, 12A Broughton Street Lane Edinburgh, GB Eh1 3ly |
| Contact | Edwin Lindsay |
| Correspondent | Edwin Lindsay Current Health Ltd Playfair House, 12A Broughton Street Lane Edinburgh, GB Eh1 3ly |
| 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 | 2019-01-16 |
| Decision Date | 2019-03-27 |