FDA 510(k)

AlertWatch:OB

K-Number: K173715 · 2018-04-23

Decision Date2018-04-23

Product CodeHGM

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

AlertWatch:OB is the device name listed in this FDA 510(k) record. The listed applicant is Alertwatch, Inc.. It received FDA 510(k) clearance on 2018-04-23 under 510(k) 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. The listed applicant is Alertwatch, Inc.. The 510(k) number is K173715.

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

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

Who is the listed applicant for AlertWatch:OB?

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:OB?

The FDA product code for AlertWatch:OB is HGM.

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.

K210160AlertWatch:AC 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.