FDA 510(k)

Ova+ (K-OVAP-USA)

Número K: K230926 · 2023-12-15

Data da decisão2023-12-15

Código do produtoNUH

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Ova+ (K-OVAP-USA) is the device name listed in this FDA 510(k) record. The listed applicant is Tenscare, Ltd.. It received FDA 510(k) clearance on 2023-12-15 under 510(k) number K230926. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Ova+ (K-OVAP-USA)?

Ova+ (K-OVAP-USA) is a medical device that received FDA 510(k) clearance on 2023-12-15. The listed applicant is Tenscare, Ltd.. The 510(k) number is K230926.

When did Ova+ (K-OVAP-USA) receive FDA 510(k) clearance?

Ova+ (K-OVAP-USA) received FDA 510(k) clearance on 2023-12-15, under 510(k) number K230926.

Who is the listed applicant for Ova+ (K-OVAP-USA)?

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

What is the FDA product code for Ova+ (K-OVAP-USA)?

The FDA product code for Ova+ (K-OVAP-USA) is NUH.

Outros registros que listam Tenscare, Ltd. como candidato(a)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

K232441Unipro (K-UNIPRO-US)K230983Unicare (K-UNICARE-USA)K231053Unicare (K-UNICARE-USA)K200694Perfect EMS K191312Perfect PFE

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Fonte oficial

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