Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

KardiaMobile Card

K-Number: K211668 · 2021-11-30

ApplicantAliveCor, Inc.
Decision Date2021-11-30
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

KardiaMobile Card is the device name listed in this FDA 510(k) record. The listed applicant is AliveCor, Inc.. It received FDA 510(k) clearance on 2021-11-30 under 510(k) number K211668. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KardiaMobile Card?

KardiaMobile Card is a medical device that received FDA 510(k) clearance on 2021-11-30. The listed applicant is AliveCor, Inc.. The 510(k) number is K211668.

When did KardiaMobile Card receive FDA 510(k) clearance?

KardiaMobile Card received FDA 510(k) clearance on 2021-11-30, under 510(k) number K211668.

Who is the listed applicant for KardiaMobile Card?

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

What is the FDA product code for KardiaMobile Card?

The FDA product code for KardiaMobile Card is DXH. This falls under the Hematology category.

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.

NCT06271577Smartphone Twelve-Lead ECG Utility In ST-Elevation Myocardial Infarction IIRECRUITING

Other records listing AliveCor, 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.

K252589Corvair MonzaK232035ImpalaK231010CorvairK220350KardiaMobile 6LK212662AliveCor QT ServiceK210753KardiaMobile 6L

View all 13 devices →

Related Devices (Code: DXH)

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.

K250233PreemptiveAI Clinical SDKMeasure Labs, Inc. (Dba Preemptiveai, Inc.)K250258HeartBeam AIMIGo with 12-L ECG Synthesis Software SystemHeartbeam, Inc.K243438MEMO Patch M (MPT-E08R-UNC01)Huinno Co., Ltd.K243981Hexoskin Medical System (7100-00016)Carre Technologies, Inc.K243003VitalSigns 1-Lead Holter (VSH101)VitalSigns Technology Co., Ltd.K233521QT ECG (QTERD100)QT Medical, 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.

↑