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)

AutoChamber

K-Number: K240786 · 2024-10-10

ApplicantHeartLung Corporation
Decision Date2024-10-10
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AutoChamber is a medical device manufactured by HeartLung Corporation. It received FDA 510(k) clearance on 2024-10-10 under approval number K240786. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AutoChamber?

AutoChamber is a medical device that received FDA 510(k) clearance on 2024-10-10. It is manufactured by HeartLung Corporation. The 510(k) number is K240786.

When was AutoChamber approved by the FDA?

AutoChamber received FDA 510(k) clearance on 2024-10-10, under approval number K240786.

What company makes AutoChamber?

AutoChamber is manufactured by HeartLung Corporation.

What is the FDA product code for AutoChamber?

The FDA product code for AutoChamber is QIH.

Other Devices by HeartLung Corporation

K213760ABMD Software K252029AI-CVD

Related Devices (Code: QIH)

K191647QLAB Advanced Quantification SoftwarePhilips Health Care K191171EchoGo CoreUltromics, Ltd. K201195syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc. K202013WRDensity by Whiterabbit.aiWhiterabbit.Ai, Inc. K202546LVivo SeamlessDia Imaging Analysis, Ltd. K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, 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.

↑