FDA 510(k)

Système AquaShield CO2, Système AquaShield CO2-PENTAX, Système AquaShield CO2-FUJIFILM

Numéro K : K191559 · 2019-08-01

DemandeurUnited States Endoscopy Group, Inc.

Date de décision2019-08-01

Code produitFEQ

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM is the device name listed in this FDA 510(k) record. The listed applicant is United States Endoscopy Group, Inc.. It received FDA 510(k) clearance on 2019-08-01 under 510(k) number K191559. The device is classified under product code FEQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM?

AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM is a medical device that received FDA 510(k) clearance on 2019-08-01. The listed applicant is United States Endoscopy Group, Inc.. The 510(k) number is K191559.

When did AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM receive FDA 510(k) clearance?

AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM received FDA 510(k) clearance on 2019-08-01, under 510(k) number K191559.

Who is the listed applicant for AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM?

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

What is the FDA product code for AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM?

The FDA product code for AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM is FEQ.

Essais cliniques associés

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Dispositifs connexes (Code : FEQ)

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Source officielle

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