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FDA 510(k)

Laminar P1 (LDH-HW-001)

N.º K: K242487 · 2024-12-13

SolicitanteLaminar Digital Health, Inc.
Fecha de decisión2024-12-13
Código de productoJAF
Comité asesorRA
DecisiónSubstantially Equivalent

Resumen del dispositivo

Laminar P1 (LDH-HW-001) is the device name listed in this FDA 510(k) record. The listed applicant is Laminar Digital Health, Inc.. It received FDA 510(k) clearance on 2024-12-13 under 510(k) number K242487. The device is classified under product code JAF. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Laminar P1 (LDH-HW-001)?

Laminar P1 (LDH-HW-001) is a medical device that received FDA 510(k) clearance on 2024-12-13. The listed applicant is Laminar Digital Health, Inc.. The 510(k) number is K242487.

When did Laminar P1 (LDH-HW-001) receive FDA 510(k) clearance?

Laminar P1 (LDH-HW-001) received FDA 510(k) clearance on 2024-12-13, under 510(k) number K242487.

Who is the listed applicant for Laminar P1 (LDH-HW-001)?

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

What is the FDA product code for Laminar P1 (LDH-HW-001)?

The FDA product code for Laminar P1 (LDH-HW-001) is JAF.

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Fuente oficial

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