FDA 510(k)

ElintMAX Respiratory Monitor (ElintMAX Monitor A1)

Número K: K260226 · 2026-09-16

Data da decisão2026-09-16

Código do produtoBZK

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

ElintMAX Respiratory Monitor (ElintMAX Monitor A1) is the device name listed in this FDA 510(k) record. The listed applicant is Amptron Medical, Inc.. It received FDA 510(k) clearance on 2026-09-16 under 510(k) number K260226. The device is classified under product code BZK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ElintMAX Respiratory Monitor (ElintMAX Monitor A1)?

ElintMAX Respiratory Monitor (ElintMAX Monitor A1) is a medical device that received FDA 510(k) clearance on 2026-09-16. The listed applicant is Amptron Medical, Inc.. The 510(k) number is K260226.

When did ElintMAX Respiratory Monitor (ElintMAX Monitor A1) receive FDA 510(k) clearance?

ElintMAX Respiratory Monitor (ElintMAX Monitor A1) received FDA 510(k) clearance on 2026-09-16, under 510(k) number K260226.

Who is the listed applicant for ElintMAX Respiratory Monitor (ElintMAX Monitor A1)?

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

What is the FDA product code for ElintMAX Respiratory Monitor (ElintMAX Monitor A1)?

The FDA product code for ElintMAX Respiratory Monitor (ElintMAX Monitor A1) is BZK.

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Fonte oficial

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