FDA 510(k)

Tamper Evident Cap For use with ENFit Syringes

N.º K: K170672 · 2017-10-06

SolicitanteInternational Medical Industries, Inc.

Fecha de decisión2017-10-06

Código de productoPNR

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Tamper Evident Cap For use with ENFit Syringes is the device name listed in this FDA 510(k) record. The listed applicant is International Medical Industries, Inc.. It received FDA 510(k) clearance on 2017-10-06 under 510(k) number K170672. The device is classified under product code PNR. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Tamper Evident Cap For use with ENFit Syringes?

Tamper Evident Cap For use with ENFit Syringes is a medical device that received FDA 510(k) clearance on 2017-10-06. The listed applicant is International Medical Industries, Inc.. The 510(k) number is K170672.

When did Tamper Evident Cap For use with ENFit Syringes receive FDA 510(k) clearance?

Tamper Evident Cap For use with ENFit Syringes received FDA 510(k) clearance on 2017-10-06, under 510(k) number K170672.

Who is the listed applicant for Tamper Evident Cap For use with ENFit Syringes?

The FDA 510(k) record lists International Medical Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tamper Evident Cap For use with ENFit Syringes?

The FDA product code for Tamper Evident Cap For use with ENFit Syringes is PNR.

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Otros registros que enlistan a International Medical Industries, Inc. como solicitante

K231095Tamper Evident Cap K201031NRFit® Caps, Male and Female Neuraxial Tip Caps K193192Tamper Evident Cap K190305Cap Aditivo K182545Tamper Evident Cap with Male Luer Lock K173577Guarded Luer Connector

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Dispositivos relacionados (Código: PNR)

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.