Triangle System— 510(k) K183319

Substantially Equivalent

AliveCor, Inc.

FDA 510(k) clearance K183319 for Triangle System, Substantially Equivalent on 2019-05-10. Applicant: AliveCor, Inc..

Clearance details

Applicant: AliveCor, Inc.
Product code: Code DXH
Advisory panel: Cardiovascular
Date received: 2018-11-30
Decision date: 2019-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

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