Cleared Traditional

K200445 - The C100 Contactless Breathing Monitor
(FDA 510(k) Clearance)

K200445 · Circadia Technologies, Ltd. · Anesthesiology

Jun 2020

Decision

121d

Days

Class 2

Risk

K200445 is an FDA 510(k) clearance for the The C100 Contactless Breathing Monitor, a Monitor, Breathing Frequency (Class II — Special Controls, product code BZQ), submitted by Circadia Technologies, Ltd. (Croydon, GB). The FDA issued a Cleared decision on June 24, 2020, 121 days after receiving the submission on February 24, 2020. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2375.

Submission Details

510(k) Number	K200445 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 24, 2020
Decision Date	June 24, 2020
Days to Decision	121 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF