FDA 510(k)

ScannerSide DoseCheck

Número K: K171261 · 2017-08-18

Data da decisão2017-08-18

Código do produtoJAK

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

ScannerSide DoseCheck is the device name listed in this FDA 510(k) record. The listed applicant is Right Dose, Inc.. It received FDA 510(k) clearance on 2017-08-18 under 510(k) number K171261. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ScannerSide DoseCheck?

ScannerSide DoseCheck is a medical device that received FDA 510(k) clearance on 2017-08-18. The listed applicant is Right Dose, Inc.. The 510(k) number is K171261.

When did ScannerSide DoseCheck receive FDA 510(k) clearance?

ScannerSide DoseCheck received FDA 510(k) clearance on 2017-08-18, under 510(k) number K171261.

Who is the listed applicant for ScannerSide DoseCheck?

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

What is the FDA product code for ScannerSide DoseCheck?

The FDA product code for ScannerSide DoseCheck is JAK.

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