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FDA 510(k)

IM007

K-Number: K210543 · 2021-11-03

ApplicantImplicity, Inc.
Decision Date2021-11-03
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

IM007 is a medical device manufactured by Implicity, Inc.. It received FDA 510(k) clearance on 2021-11-03 under approval number K210543. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IM007?

IM007 is a medical device that received FDA 510(k) clearance on 2021-11-03. It is manufactured by Implicity, Inc.. The 510(k) number is K210543.

When was IM007 approved by the FDA?

IM007 received FDA 510(k) clearance on 2021-11-03, under approval number K210543.

What company makes IM007?

IM007 is manufactured by Implicity, Inc..

What is the FDA product code for IM007?

The FDA product code for IM007 is DQK.

Other Devices by Implicity, Inc.

K230842SignalHF (IM008)

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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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