The following data is part of a premarket notification filed by Circadia Technologies Ltd. with the FDA for The C100 Contactless Breathing Monitor.
| Device ID | K200445 |
| 510k Number | K200445 |
| Device Name: | The C100 Contactless Breathing Monitor |
| Classification | Monitor, Breathing Frequency |
| Applicant | Circadia Technologies Ltd. 6 Delmey Close Croydon, GB Cr0 5qd |
| Contact | Michal Maslik |
| Correspondent | Andrew Wu Rook Quality Systems, Inc. 1155 Mount Vernon Highway, Suite 800 Dunwoody, GA 30338 |
| Product Code | BZQ |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-24 |
| Decision Date | 2020-06-24 |