FDA 510(k)

Dispositivo de Compressão Arterial ARTAIRA (AACD01)

Número K: K240499 · 2024-10-11

Data da decisão2024-10-11

Código do produtoJOW

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

ARTAIRA Arterial Compression Device (AACD01) is the device name listed in this FDA 510(k) record. The listed applicant is Airos Medical, Inc.. It received FDA 510(k) clearance on 2024-10-11 under 510(k) number K240499. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ARTAIRA Arterial Compression Device (AACD01)?

ARTAIRA Arterial Compression Device (AACD01) is a medical device that received FDA 510(k) clearance on 2024-10-11. The listed applicant is Airos Medical, Inc.. The 510(k) number is K240499.

When did ARTAIRA Arterial Compression Device (AACD01) receive FDA 510(k) clearance?

ARTAIRA Arterial Compression Device (AACD01) received FDA 510(k) clearance on 2024-10-11, under 510(k) number K240499.

Who is the listed applicant for ARTAIRA Arterial Compression Device (AACD01)?

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

What is the FDA product code for ARTAIRA Arterial Compression Device (AACD01)?

The FDA product code for ARTAIRA Arterial Compression Device (AACD01) is JOW.

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Outros registros que listam Airos Medical, Inc. como candidato(a)

K223193Dispositivo de Compressão Sequencial AIROS 8P K223195Dispositivo de Compressão Sequencial AIROS 6P K193069Dispositivo de Compressão Sequencial AIROS 6 K193068Dispositivo de Compressão Sequencial AIROS 8 K172779Dispositivo de Compressão Sequencial AIROS 8 K172770Dispositivo de Compressão Sequencial AIROS 6

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Fonte oficial

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