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FDA 510(k)

AlertWatch: OR

K-Number: K153335 · 2016-03-15

ApplicantAlertwatch, LLC
Decision Date2016-03-15
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AlertWatch: OR is a medical device manufactured by Alertwatch, LLC. It received FDA 510(k) clearance on 2016-03-15 under approval number K153335. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AlertWatch: OR?

AlertWatch: OR is a medical device that received FDA 510(k) clearance on 2016-03-15. It is manufactured by Alertwatch, LLC. The 510(k) number is K153335.

When was AlertWatch: OR approved by the FDA?

AlertWatch: OR received FDA 510(k) clearance on 2016-03-15, under approval number K153335.

What company makes AlertWatch: OR?

AlertWatch: OR is manufactured by Alertwatch, LLC.

What is the FDA product code for AlertWatch: OR?

The FDA product code for AlertWatch: OR is MWI.

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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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