FDA 510(k)

AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM

K-Nummer: K191559 · 2019-08-01

AntragstellerUnited States Endoscopy Group, Inc.

Entscheidungsdatum2019-08-01

ProduktcodeFEQ

BeratungsausschussGU

EntscheidungSubstantially Equivalent

Produktübersicht

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.

Häufig gestellte Fragen

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.

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Weitere Einträge mit United States Endoscopy Group, Inc. als Antragsteller

K192265gi-4000 Electrosurgical Generator K200745Lariat, Hot/Cold Snare K192059Bio Guard Air/Water & Suction Valves K182909Roth Net Retriever Product Line K182258AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - Fujifilm K173650AquaShield System CO2- Fujifilm

Alle 10 Geräte anzeigen →

Verwandte Geräte (Code: FEQ)

K220395EndoGator Endoscopy Irrigation TubingSTERIS Corporation K182258AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - FujifilmUnited States Endoscopy Group, Inc.K173650AquaShield System CO2- FujifilmUnited States Endoscopy Group, Inc.K163424AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINONUnited State Endoscopy Group, Inc.K162152Erbe’s CO2 Tubing/Cap SetsErbe USA, Inc.K161482EndoChoice Water Bottle Cap Irrigation SystemEndochoice, Inc.

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