FDA 510(k)

MouthLab Vital Signs Monitoring System

Numéro K : K201635 · 2021-02-06

DemandeurMultisensor Diagnostics (Dba Aidar Health)

Date de décision2021-02-06

Code produitMWI

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

MouthLab Vital Signs Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Multisensor Diagnostics (Dba Aidar Health). It received FDA 510(k) clearance on 2021-02-06 under 510(k) number K201635. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the MouthLab Vital Signs Monitoring System?

MouthLab Vital Signs Monitoring System is a medical device that received FDA 510(k) clearance on 2021-02-06. The listed applicant is Multisensor Diagnostics (Dba Aidar Health). The 510(k) number is K201635.

When did MouthLab Vital Signs Monitoring System receive FDA 510(k) clearance?

MouthLab Vital Signs Monitoring System received FDA 510(k) clearance on 2021-02-06, under 510(k) number K201635.

Who is the listed applicant for MouthLab Vital Signs Monitoring System?

The FDA 510(k) record lists Multisensor Diagnostics (Dba Aidar Health) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MouthLab Vital Signs Monitoring System?

The FDA product code for MouthLab Vital Signs Monitoring System is MWI.

Essais cliniques associés

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Dispositifs connexes (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

Source officielle

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