The following data is part of a premarket notification filed by Current Health with the FDA for Current Health Monitoring System Gen 2 (g2).
Device ID | K210133 |
510k Number | K210133 |
Device Name: | Current Health Monitoring System Gen 2 (G2) |
Classification | System, Network And Communication, Physiological Monitors |
Applicant | Current Health Playfair House, 6 Broughton Street Lane Edinburgh, GB Eh 1 3ly |
Contact | Phil Bromley |
Correspondent | Phil Bromley Current Health Playfair House, 6 Broughton Street Lane Edinburgh, GB Eh 1 3ly |
Product Code | MSX |
Subsequent Product Code | BZG |
Subsequent Product Code | DQA |
Subsequent Product Code | DRG |
Subsequent Product Code | FLL |
Subsequent Product Code | GZQ |
CFR Regulation Number | 870.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-01-19 |
Decision Date | 2021-09-03 |