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FDA 510(k)

Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models)

N.º K: K243149 · 2024-12-20

SolicitanteCongruence Medical Solutions, LLC
Fecha de decisión2024-12-20
Código de productoQLY
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models) is the device name listed in this FDA 510(k) record. The listed applicant is Congruence Medical Solutions, LLC. It received FDA 510(k) clearance on 2024-12-20 under 510(k) number K243149. The device is classified under product code QLY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models)?

Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models) is a medical device that received FDA 510(k) clearance on 2024-12-20. The listed applicant is Congruence Medical Solutions, LLC. The 510(k) number is K243149.

When did Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models) receive FDA 510(k) clearance?

Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models) received FDA 510(k) clearance on 2024-12-20, under 510(k) number K243149.

Who is the listed applicant for Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models)?

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

What is the FDA product code for Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models)?

The FDA product code for Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models) is QLY.

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Dispositivos relacionados (Código: QLY)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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