FDA 510(k) clearance · back to tracker

AcQMap® High Resolution Imaging and Mapping System

Acutus Medical, Inc. cleared K230606 on 2023-05-02, decision: substantially equivalent

K-number

K230606

Sponsor

Acutus Medical, Inc.

Device

AcQMap® High Resolution Imaging and Mapping System

Class

Class II

Decision

Substantially Equivalent

Decision date

2023-05-02

Product code

DQK

Advisory committee

Cardiovascular

Medical specialty

Cardiovascular

Regulation number

870.1425

Official FDA record

Open K230606on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.