FDA 510(k)

AlertWatch: OR

K-Number: K153335 · 2016-03-15

Decision Date2016-03-15

Product CodeMWI

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

AlertWatch: OR is the device name listed in this FDA 510(k) record. The listed applicant is Alertwatch, LLC. It received FDA 510(k) clearance on 2016-03-15 under 510(k) 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. The listed applicant is Alertwatch, LLC. The 510(k) number is K153335.

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

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

Who is the listed applicant for AlertWatch: OR?

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

What is the FDA product code for AlertWatch: OR?

The FDA product code for AlertWatch: OR is MWI.

Other records listing Alertwatch, LLC 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 K173715AlertWatch:OB

Related Devices (Code: MWI)

K260438Vital Signs Monitor (CLEO2)Infinium Medical, Inc.K253417Masimo Root Monitoring SystemMasimo Corporation K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark Corporation K253436c-med0 alphaCosinuss GmbH K250135WAVE Clinical Platform (2.0.000)Baxter Healthcare Corp/ Excel Medical K241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV

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.