FDA 510(k)

UltraDrape UGPIV Barrier and Securement (34-15)

Número K: K233965 · 2024-08-15

Data da decisão2024-08-15

Código do produtoITX

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

UltraDrape UGPIV Barrier and Securement (34-15) is the device name listed in this FDA 510(k) record. The listed applicant is Parker Laboratories, Inc.. It received FDA 510(k) clearance on 2024-08-15 under 510(k) number K233965. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the UltraDrape UGPIV Barrier and Securement (34-15)?

UltraDrape UGPIV Barrier and Securement (34-15) is a medical device that received FDA 510(k) clearance on 2024-08-15. The listed applicant is Parker Laboratories, Inc.. The 510(k) number is K233965.

When did UltraDrape UGPIV Barrier and Securement (34-15) receive FDA 510(k) clearance?

UltraDrape UGPIV Barrier and Securement (34-15) received FDA 510(k) clearance on 2024-08-15, under 510(k) number K233965.

Who is the listed applicant for UltraDrape UGPIV Barrier and Securement (34-15)?

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

What is the FDA product code for UltraDrape UGPIV Barrier and Securement (34-15)?

The FDA product code for UltraDrape UGPIV Barrier and Securement (34-15) is ITX.

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