Cala ONE— 510(k) DEN170028

Unknown

Cala Health, Inc.

FDA 510(k) clearance DEN170028 for Cala ONE, Unknown on 2018-04-26. Applicant: Cala Health, Inc.. Device class: 2.

Clearance details

Applicant: Cala Health, Inc.
Product code: Code QBC
Device class: Class 2
Regulation: 21 CFR 882.5897
Advisory panel: Neurology
Date received: 2017-05-17
Decision date: 2018-04-26
Decision: Unknown
Clearance type: Direct
Location: Burlingame, CA, US

View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.