FDA 510(k)

AlertWatch:AC

K-Number: K210160 · 2021-09-10

Decision Date2021-09-10

Product CodeMSX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

AlertWatch:AC is the device name listed in this FDA 510(k) record. The listed applicant is Alertwatch, Inc.. It received FDA 510(k) clearance on 2021-09-10 under 510(k) 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. The listed applicant is Alertwatch, Inc.. The 510(k) number is K210160.

When did AlertWatch:AC receive FDA 510(k) clearance?

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

Who is the listed applicant for AlertWatch:AC?

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

What is the FDA product code for AlertWatch:AC?

The FDA product code for AlertWatch:AC is MSX.

Other records listing Alertwatch, 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.

K173715AlertWatch:OB K153335AlertWatch: OR

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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.