DeviceClearance

HeartBeam AIMIGo(TM) System— 510(k) K231424

Substantially Equivalent

Heartbeam, Inc.

FDA 510(k) clearance K231424 for HeartBeam AIMIGo(TM) System, Substantially Equivalent on 2024-12-13. Applicant: Heartbeam, Inc.. Device class: 2.

Clearance details

Applicant
Heartbeam, Inc.
Product code
Code MWJ
Device class
Class 2
Regulation
21 CFR 870.2800
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Santa Clara, CA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code MWJ

product code MWJ
Other
1
Total
1

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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