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FDA 510(k)

AlertWatch:OB

K-Number: K173715 · 2018-04-23

ApplicantAlertwatch, Inc.
Decision Date2018-04-23
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

AlertWatch:OB is a medical device manufactured by Alertwatch, Inc.. It received FDA 510(k) clearance on 2018-04-23 under approval number K173715. The device is classified under product code HGM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AlertWatch:OB?

AlertWatch:OB is a medical device that received FDA 510(k) clearance on 2018-04-23. It is manufactured by Alertwatch, Inc.. The 510(k) number is K173715.

When was AlertWatch:OB approved by the FDA?

AlertWatch:OB received FDA 510(k) clearance on 2018-04-23, under approval number K173715.

What company makes AlertWatch:OB?

AlertWatch:OB is manufactured by Alertwatch, Inc..

What is the FDA product code for AlertWatch:OB?

The FDA product code for AlertWatch:OB is HGM.

Other Devices by Alertwatch, Inc.

K210160AlertWatch:AC

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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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