FDA 510(k)

iOS CamAPS FX

N.º K: K261896 · 2026-09-16

SolicitanteCamDiab

Fecha de decisión2026-09-16

Código de productoQJI

Comité asesorCH

DecisiónSubstantially Equivalent

Resumen del dispositivo

iOS CamAPS FX is the device name listed in this FDA 510(k) record. The listed applicant is CamDiab. It received FDA 510(k) clearance on 2026-09-16 under 510(k) number K261896. The device is classified under product code QJI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the iOS CamAPS FX?

iOS CamAPS FX is a medical device that received FDA 510(k) clearance on 2026-09-16. The listed applicant is CamDiab. The 510(k) number is K261896.

When did iOS CamAPS FX receive FDA 510(k) clearance?

iOS CamAPS FX received FDA 510(k) clearance on 2026-09-16, under 510(k) number K261896.

Who is the listed applicant for iOS CamAPS FX?

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

What is the FDA product code for iOS CamAPS FX?

The FDA product code for iOS CamAPS FX is QJI.

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Fuente oficial

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