FDA 510(k)

TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear)

Número K: K223108 · 2023-01-19

Data da decisão2023-01-19

Código do produtoOLO

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear) is the device name listed in this FDA 510(k) record. The listed applicant is Medos International SARL. It received FDA 510(k) clearance on 2023-01-19 under 510(k) number K223108. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear)?

TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear) is a medical device that received FDA 510(k) clearance on 2023-01-19. The listed applicant is Medos International SARL. The 510(k) number is K223108.

When did TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear) receive FDA 510(k) clearance?

TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear) received FDA 510(k) clearance on 2023-01-19, under 510(k) number K223108.

Who is the listed applicant for TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear)?

The FDA 510(k) record lists Medos International SARL as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear)?

The FDA product code for TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear) is OLO.

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Fonte oficial

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