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FDA 510(k)

Atrial Fibrillation History Feature

K-Number: K213971 · 2022-06-03

ApplicantApple, Inc.
Decision Date2022-06-03
Product CodeQDB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Atrial Fibrillation History Feature is the device name listed in this FDA 510(k) record. The listed applicant is Apple, Inc.. It received FDA 510(k) clearance on 2022-06-03 under 510(k) number K213971. The device is classified under product code QDB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Atrial Fibrillation History Feature?

Atrial Fibrillation History Feature is a medical device that received FDA 510(k) clearance on 2022-06-03. The listed applicant is Apple, Inc.. The 510(k) number is K213971.

When did Atrial Fibrillation History Feature receive FDA 510(k) clearance?

Atrial Fibrillation History Feature received FDA 510(k) clearance on 2022-06-03, under 510(k) number K213971.

Who is the listed applicant for Atrial Fibrillation History Feature?

The FDA 510(k) record lists Apple, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Atrial Fibrillation History Feature?

The FDA product code for Atrial Fibrillation History Feature is QDB.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05298553Diagnostic Accuracy of WEARable TECHnology Single-lead ECG in Detecting Cardiac ArrhythmiasCOMPLETEDNCT06671171Wearable Assessment of Thoracic, Cardiac Health and Exercise Performance TrialCOMPLETEDNCT06832579SmartWatch-driven AF Detection in Stroke PatientsACTIVE_NOT_RECRUITINGNCT07663799Wearable Assessment of Thoracic, Cardiac Health and Exercise Performance Trial ProspectiveNOT_YET_RECRUITINGNCT05836987The Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial FibrillationRECRUITINGNCT07515040Comparative Study on the Safety and Efficacy of Using AccuSafe Transseptal Guidewire Versus Traditional Transseptal Needle for Transseptal Puncture in non-or Free- GuidanceRECRUITING

Other records listing Apple, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253582Medical Imaging Calibration Feature (MICF)K250507Hypertension Notification Feature (HTNF)K250143Digital Prism Correction Feature (DPCF)K242058Digital Prism Correction Feature (DPCF)K240929Sleep Apnea Notification Feature (SANF)K231173Irregular Rhythm Notification Feature (IRNF)

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Related Devices (Code: QDB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231173Irregular Rhythm Notification Feature (IRNF)Apple, Inc.K212372Fitbit Irregular Rhythm NotificationsFitbit, Inc.K212516IRNF AppApple, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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