FDA 510(k)

Spinal Manometer NRFit; Spinal Manometer LUER

N.º K: K170305 · 2017-07-25

SolicitantePAJUNK GmbH Medizintechnologie

Fecha de decisión2017-07-25

Código de productoFMJ

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Spinal Manometer NRFit; Spinal Manometer LUER is the device name listed in this FDA 510(k) record. The listed applicant is PAJUNK GmbH Medizintechnologie. It received FDA 510(k) clearance on 2017-07-25 under 510(k) number K170305. The device is classified under product code FMJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Spinal Manometer NRFit; Spinal Manometer LUER?

Spinal Manometer NRFit; Spinal Manometer LUER is a medical device that received FDA 510(k) clearance on 2017-07-25. The listed applicant is PAJUNK GmbH Medizintechnologie. The 510(k) number is K170305.

When did Spinal Manometer NRFit; Spinal Manometer LUER receive FDA 510(k) clearance?

Spinal Manometer NRFit; Spinal Manometer LUER received FDA 510(k) clearance on 2017-07-25, under 510(k) number K170305.

Who is the listed applicant for Spinal Manometer NRFit; Spinal Manometer LUER?

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

What is the FDA product code for Spinal Manometer NRFit; Spinal Manometer LUER?

The FDA product code for Spinal Manometer NRFit; Spinal Manometer LUER is FMJ.

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Fuente oficial

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