The C100 Contactless Breathing Monitor— 510(k) K200445

Name: FDA 510(k) clearance K200445
Creator: U.S. Food and Drug Administration
Published: 2020-06-24

Substantially Equivalent

Circadia Technologies, Ltd.

FDA 510(k) clearance K200445 for The C100 Contactless Breathing Monitor, Substantially Equivalent on 2020-06-24. Applicant: Circadia Technologies, Ltd.. Device class: 2.

Clearance details

Applicant: Circadia Technologies, Ltd.
Product code: Code BZQ
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 2020-02-24
Decision date: 2020-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Croydon, GB

Download summary PDF View on FDA.gov ↗

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