FDA 510(k)

SignalHF (IM008)

K-Number: K230842 · 2023-10-25

Decision Date2023-10-25

Product CodeQNL

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

SignalHF (IM008) is the device name listed in this FDA 510(k) record. The listed applicant is Implicity, Inc.. It received FDA 510(k) clearance on 2023-10-25 under 510(k) 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. The listed applicant is Implicity, Inc.. The 510(k) number is K230842.

When did SignalHF (IM008) receive FDA 510(k) clearance?

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

Who is the listed applicant for SignalHF (IM008)?

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

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

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

Other records listing Implicity, 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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.