FDA 510(k)

SPY Portable Handheld Imaging (SPY-PHI) System

Número K: K230727 · 2023-06-05

RequerenteNovadaq Technologies Ulc (A Part of Stryker)

Data da decisão2023-06-05

Código do produtoIZI

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

SPY Portable Handheld Imaging (SPY-PHI) System is the device name listed in this FDA 510(k) record. The listed applicant is Novadaq Technologies Ulc (A Part of Stryker). It received FDA 510(k) clearance on 2023-06-05 under 510(k) number K230727. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SPY Portable Handheld Imaging (SPY-PHI) System?

SPY Portable Handheld Imaging (SPY-PHI) System is a medical device that received FDA 510(k) clearance on 2023-06-05. The listed applicant is Novadaq Technologies Ulc (A Part of Stryker). The 510(k) number is K230727.

When did SPY Portable Handheld Imaging (SPY-PHI) System receive FDA 510(k) clearance?

SPY Portable Handheld Imaging (SPY-PHI) System received FDA 510(k) clearance on 2023-06-05, under 510(k) number K230727.

Who is the listed applicant for SPY Portable Handheld Imaging (SPY-PHI) System?

The FDA 510(k) record lists Novadaq Technologies Ulc (A Part of Stryker) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPY Portable Handheld Imaging (SPY-PHI) System?

The FDA product code for SPY Portable Handheld Imaging (SPY-PHI) System is IZI.

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