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FDA 510(k)

CardioSTAT® ECG Test Solution

K-Number: K223049 · 2023-03-22

ApplicantIcentia, Inc.
Decision Date2023-03-22
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CardioSTAT® ECG Test Solution is the device name listed in this FDA 510(k) record. The listed applicant is Icentia, Inc.. It received FDA 510(k) clearance on 2023-03-22 under 510(k) number K223049. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CardioSTAT® ECG Test Solution?

CardioSTAT® ECG Test Solution is a medical device that received FDA 510(k) clearance on 2023-03-22. The listed applicant is Icentia, Inc.. The 510(k) number is K223049.

When did CardioSTAT® ECG Test Solution receive FDA 510(k) clearance?

CardioSTAT® ECG Test Solution received FDA 510(k) clearance on 2023-03-22, under 510(k) number K223049.

Who is the listed applicant for CardioSTAT® ECG Test Solution?

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

What is the FDA product code for CardioSTAT® ECG Test Solution?

The FDA product code for CardioSTAT® ECG Test Solution is DSH.

Related Devices (Code: DSH)

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.

K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.K252389Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)Smwmed, Inc.K253293VitaloJAK Clinic (Model 7100)Vitalograph , Ltd.K243650Zio® monitor (DFG0001)iRhythm Technologies, Inc.K243603AeviceMDAevice Health Pte. , Ltd.K242583AT-Patch (ATP-C130/ATP-C70)Atsens Co., Ltd.

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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