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FDA 510(k)

AlertWatch:AC

K-Number: K210160 · 2021-09-10

ApplicantAlertwatch, Inc.
Decision Date2021-09-10
Product CodeMSX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AlertWatch:AC is a medical device manufactured by Alertwatch, Inc.. It received FDA 510(k) clearance on 2021-09-10 under approval number K210160. The device is classified under product code MSX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AlertWatch:AC?

AlertWatch:AC is a medical device that received FDA 510(k) clearance on 2021-09-10. It is manufactured by Alertwatch, Inc.. The 510(k) number is K210160.

When was AlertWatch:AC approved by the FDA?

AlertWatch:AC received FDA 510(k) clearance on 2021-09-10, under approval number K210160.

What company makes AlertWatch:AC?

AlertWatch:AC is manufactured by Alertwatch, Inc..

What is the FDA product code for AlertWatch:AC?

The FDA product code for AlertWatch:AC is MSX.

Other Devices by Alertwatch, Inc.

K173715AlertWatch:OB

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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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