FDA 510(k)

JTL-250-01

Número K: K182732 · 2019-11-18

Data da decisão2019-11-18

Código do produtoMUU

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

JTL-250-01 is the device name listed in this FDA 510(k) record. The listed applicant is Jointechlabs, Inc.. It received FDA 510(k) clearance on 2019-11-18 under 510(k) number K182732. The device is classified under product code MUU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the JTL-250-01?

JTL-250-01 is a medical device that received FDA 510(k) clearance on 2019-11-18. The listed applicant is Jointechlabs, Inc.. The 510(k) number is K182732.

When did JTL-250-01 receive FDA 510(k) clearance?

JTL-250-01 received FDA 510(k) clearance on 2019-11-18, under 510(k) number K182732.

Who is the listed applicant for JTL-250-01?

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

What is the FDA product code for JTL-250-01?

The FDA product code for JTL-250-01 is MUU.

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Fonte oficial

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