CER-S— 510(k) K193177

Substantially Equivalent

Cardiocalm

FDA 510(k) clearance K193177 for CER-S, Substantially Equivalent on 2020-08-26. Applicant: Cardiocalm.

Clearance details

Applicant: Cardiocalm
Product code: Code MLO
Advisory panel: Cardiovascular
Date received: 2019-11-18
Decision date: 2020-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montichiari, IT

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