FDA 510(k)

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

Numéro K : K193343 · 2020-04-20

Date de décision2020-04-20

Code produitDRG

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Autres dossiers indiquant Vitalconnect, Inc. en tant que demandeur

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Source officielle

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