FDA 510(k)

Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System

K-Nummer: K212704 · 2021-09-24

Entscheidungsdatum2021-09-24

ProduktcodeIYN

BeratungsausschussRA

EntscheidungSubstantially Equivalent

Produktübersicht

Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems. It received FDA 510(k) clearance on 2021-09-24 under 510(k) number K212704. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System?

Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2021-09-24. The listed applicant is Philips Medical Systems. The 510(k) number is K212704.

When did Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System receive FDA 510(k) clearance?

Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System received FDA 510(k) clearance on 2021-09-24, under 510(k) number K212704.

Who is the listed applicant for Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System?

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

What is the FDA product code for Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System?

The FDA product code for Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System is IYN.

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Weitere Einträge mit Philips Medical Systems als Antragsteller

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