FDA 510(k)

Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed)

Número K: K193343 · 2020-04-20

Data da decisão2020-04-20

Código do produtoDRG

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed) is the device name listed in this FDA 510(k) record. The listed applicant is Vitalconnect, Inc.. It received FDA 510(k) clearance on 2020-04-20 under 510(k) number K193343. 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 Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed)?

Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed) is a medical device that received FDA 510(k) clearance on 2020-04-20. The listed applicant is Vitalconnect, Inc.. The 510(k) number is K193343.

When did Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed) receive FDA 510(k) clearance?

Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed) received FDA 510(k) clearance on 2020-04-20, under 510(k) number K193343.

Who is the listed applicant for Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed)?

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 Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed)?

The FDA product code for Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed) is DRG.

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

K242129VitalRhythm K192757VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor – bag of 20, VitalPatch 7D Biosensor – bag of 20 K190916VitalPatch 7D Biosensor - single, 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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