FDA 510(k)

VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20

Número K: K190916 · 2019-06-07

Data da decisão2019-06-07

Código do produtoDRG

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20 is the device name listed in this FDA 510(k) record. The listed applicant is Vitalconnect, Inc.. It received FDA 510(k) clearance on 2019-06-07 under 510(k) number K190916. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20?

VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20 is a medical device that received FDA 510(k) clearance on 2019-06-07. The listed applicant is Vitalconnect, Inc.. The 510(k) number is K190916.

When did VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20 receive FDA 510(k) clearance?

VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20 received FDA 510(k) clearance on 2019-06-07, under 510(k) number K190916.

Who is the listed applicant for VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20?

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

What is the FDA product code for VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20?

The FDA product code for VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20 is DRG.

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Outros registros que listam Vitalconnect, Inc. como candidato(a)

K242129VitalRhythm K193343Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed)K192757VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor – bag of 20, VitalPatch 7D Biosensor – bag of 20 K183078VitalConnect Platform, VitalPatch Biosensor K163453VitalPatch® VitalConnect Platform K170973VitalWatch Software User Interface

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Fonte oficial

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