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FDA 510(k)

SignalHF (IM008)

K-Number: K230842 · 2023-10-25

ApplicantImplicity, Inc.
Decision Date2023-10-25
Product CodeQNL
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SignalHF (IM008) is a medical device manufactured by Implicity, Inc.. It received FDA 510(k) clearance on 2023-10-25 under approval number K230842. The device is classified under product code QNL. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SignalHF (IM008)?

SignalHF (IM008) is a medical device that received FDA 510(k) clearance on 2023-10-25. It is manufactured by Implicity, Inc.. The 510(k) number is K230842.

When was SignalHF (IM008) approved by the FDA?

SignalHF (IM008) received FDA 510(k) clearance on 2023-10-25, under approval number K230842.

What company makes SignalHF (IM008)?

SignalHF (IM008) is manufactured by Implicity, Inc..

What is the FDA product code for SignalHF (IM008)?

The FDA product code for SignalHF (IM008) is QNL.

Other Devices by Implicity, Inc.

K210543IM007

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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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