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

FDA 510(k)

Cleerly Labs

K-Number: K190868 · 2019-11-05

ApplicantCleerly, Inc.
Decision Date2019-11-05
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Cleerly Labs is a medical device manufactured by Cleerly, Inc.. It received FDA 510(k) clearance on 2019-11-05 under approval number K190868. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cleerly Labs?

Cleerly Labs is a medical device that received FDA 510(k) clearance on 2019-11-05. It is manufactured by Cleerly, Inc.. The 510(k) number is K190868.

When was Cleerly Labs approved by the FDA?

Cleerly Labs received FDA 510(k) clearance on 2019-11-05, under approval number K190868.

What company makes Cleerly Labs?

Cleerly Labs is manufactured by Cleerly, Inc..

What is the FDA product code for Cleerly Labs?

The FDA product code for Cleerly Labs is LLZ.

Other Devices by Cleerly, Inc.

K202280Cleerly Labs v2.0 K231335Cleerly ISCHEMIA K242338Cleerly LABS (v2.0)

Related Devices (Code: LLZ)

K161959ClearView cCADClearview Diagnostics, Inc. K163539Ez3D-i / E3Ewoosoft Co., Ltd. K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V. K160852ZiaZetta Medical Technologies, LLC K162376CAAS MR 4D FlowPie Medical Imaging BV K161322CT CoPilotZepmed, LLC

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.

↑