FDA 510(k)

EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System

Numéro K : K181485 · 2018-07-27

Date de décision2018-07-27

Code produitIYN

Comité consultatifRA

DécisionSubstantially Equivalent

Résumé du dispositif

EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Philips Ultrasound, Inc.. It received FDA 510(k) clearance on 2018-07-27 under 510(k) number K181485. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System?

EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2018-07-27. The listed applicant is Philips Ultrasound, Inc.. The 510(k) number is K181485.

When did EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System receive FDA 510(k) clearance?

EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System received FDA 510(k) clearance on 2018-07-27, under 510(k) number K181485.

Who is the listed applicant for EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System?

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

What is the FDA product code for EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System?

The FDA product code for EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System is IYN.

Essais cliniques associés

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Dispositifs connexes (Code : IYN)

Source officielle

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