Heartbeam – FDA Inspection, Sep 16, 2026

Record Details

This FDA Inspection record concerns Heartbeam, with an inspection on September 16, 2026, issued by the Center for Devices and Radiological Health, covering devices.

Company: Heartbeam
Inspection Date: September 16, 2026
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · dec63d7a-a461-4e20-8526-04cc376ef623

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number: 1336308
Project area: Postmarket Assurance: Devices

FDA Citations

ISO 13485:2016 Clause 8.2.2Complaint handling records not maintained

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FDA Inspection

HeartbeamSeptember 16, 2026