FDA 510(k)

Hang&Go PAC

Número K: K161613 · 2016-12-28

Data da decisão2016-12-28

Código do produtoLGZ

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Hang&Go PAC is the device name listed in this FDA 510(k) record. The listed applicant is Rand S.R.L.. It received FDA 510(k) clearance on 2016-12-28 under 510(k) number K161613. The device is classified under product code LGZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Hang&Go PAC?

Hang&Go PAC is a medical device that received FDA 510(k) clearance on 2016-12-28. The listed applicant is Rand S.R.L.. The 510(k) number is K161613.

When did Hang&Go PAC receive FDA 510(k) clearance?

Hang&Go PAC received FDA 510(k) clearance on 2016-12-28, under 510(k) number K161613.

Who is the listed applicant for Hang&Go PAC?

The FDA 510(k) record lists Rand S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hang&Go PAC?

The FDA product code for Hang&Go PAC is LGZ.

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