FDA 510(k)

DiamondTOUCH Inflation Device and Fluid Dispensing Syringe

Numéro K : K160107 · 2016-07-29

Date de décision2016-07-29

Code produitDXT

Comité consultatifCV

DécisionUnknown

Résumé du dispositif

DiamondTOUCH Inflation Device and Fluid Dispensing Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2016-07-29 under 510(k) number K160107. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

Questions fréquentes

What is the DiamondTOUCH Inflation Device and Fluid Dispensing Syringe?

DiamondTOUCH Inflation Device and Fluid Dispensing Syringe is a medical device that received FDA 510(k) clearance on 2016-07-29. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K160107.

When did DiamondTOUCH Inflation Device and Fluid Dispensing Syringe receive FDA 510(k) clearance?

DiamondTOUCH Inflation Device and Fluid Dispensing Syringe received FDA 510(k) clearance on 2016-07-29, under 510(k) number K160107.

Who is the listed applicant for DiamondTOUCH Inflation Device and Fluid Dispensing Syringe?

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

What is the FDA product code for DiamondTOUCH Inflation Device and Fluid Dispensing Syringe?

The FDA product code for DiamondTOUCH Inflation Device and Fluid Dispensing Syringe is DXT.

Essais cliniques associés

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Dispositifs connexes (Code : DXT)

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Source officielle

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