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FDA 510(k)

Cleerly ISCHEMIA

K-Number: K231335 · 2023-09-08

ApplicantCleerly, Inc.
Decision Date2023-09-08
Product CodeQXZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Cleerly ISCHEMIA is the device name listed in this FDA 510(k) record. The listed applicant is Cleerly, Inc.. It received FDA 510(k) clearance on 2023-09-08 under 510(k) number K231335. The device is classified under product code QXZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cleerly ISCHEMIA?

Cleerly ISCHEMIA is a medical device that received FDA 510(k) clearance on 2023-09-08. The listed applicant is Cleerly, Inc.. The 510(k) number is K231335.

When did Cleerly ISCHEMIA receive FDA 510(k) clearance?

Cleerly ISCHEMIA received FDA 510(k) clearance on 2023-09-08, under 510(k) number K231335.

Who is the listed applicant for Cleerly ISCHEMIA?

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

What is the FDA product code for Cleerly ISCHEMIA?

The FDA product code for Cleerly ISCHEMIA is QXZ.

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.

NCT06112418A Randomized Comparison of Stage-Based Care Versus Risk Factor-Based Care for Prevention of Cardiovascular EventsRECRUITINGNCT06713239A Randomized Comparison of Personalized Therapy Mgmt Based On Coronary Atherosclerotic Plaque Vs. Usual Care for Symptomatic Patients With Suspicion of CADACTIVE_NOT_RECRUITING

Other records listing Cleerly, 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.

K261210Cleerly PlaqueK260588Cleerly LABSK242338Cleerly LABS (v2.0)K202280Cleerly Labs v2.0K190868Cleerly Labs

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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