Device Classification Name |
monitor, breathing frequency
|
510(k) Number |
K200445 |
Device Name |
The C100 Contactless Breathing Monitor |
Applicant |
Circadia Technologies Ltd. |
6 Delmey Close |
Croydon,
GB
CR0 5QD
|
|
Applicant Contact |
Michal Maslik |
Correspondent |
Rook Quality Systems, Inc. |
1155 Mount Vernon Highway, Suite 800 |
Dunwoody,
GA
30338
|
|
Correspondent Contact |
Andrew Wu |
Regulation Number | 868.2375
|
Classification Product Code |
|
Date Received | 02/24/2020 |
Decision Date | 06/24/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|