FDA 510(k)

NeoGen PSR System

Номер K: K221873 · 2023-01-12

Дата решения2023-01-12

Код продуктаGEI

Консультативный комитетSU

РешениеSubstantially Equivalent

Описание устройства

NeoGen PSR System is the device name listed in this FDA 510(k) record. The listed applicant is Energist Limited. It received FDA 510(k) clearance on 2023-01-12 under 510(k) number K221873. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the NeoGen PSR System?

NeoGen PSR System is a medical device that received FDA 510(k) clearance on 2023-01-12. The listed applicant is Energist Limited. The 510(k) number is K221873.

When did NeoGen PSR System receive FDA 510(k) clearance?

NeoGen PSR System received FDA 510(k) clearance on 2023-01-12, under 510(k) number K221873.

Who is the listed applicant for NeoGen PSR System?

The FDA 510(k) record lists Energist Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NeoGen PSR System?

The FDA product code for NeoGen PSR System is GEI.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: GEI)

K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102)Stryker Instruments K261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLC K254185Potenza PrimeJeisys Medical Incorporated K262364Ellian Enigma RF DeviceEllian Corp K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.

Официальный источник

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