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FDA 510(k)

Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package

Número K: K182543 · 2018-11-14

RequerenteSnap40, Ltd.
Data da decisão2018-11-14
Código do produtoMSX
Comité consultivoCV
DecisãoSubstantially Equivalent

Resumo do dispositivo

Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package is the device name listed in this FDA 510(k) record. The listed applicant is Snap40, Ltd.. It received FDA 510(k) clearance on 2018-11-14 under 510(k) number K182543. The device is classified under product code MSX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package?

Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package is a medical device that received FDA 510(k) clearance on 2018-11-14. The listed applicant is Snap40, Ltd.. The 510(k) number is K182543.

When did Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package receive FDA 510(k) clearance?

Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package received FDA 510(k) clearance on 2018-11-14, under 510(k) number K182543.

Who is the listed applicant for Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package?

The FDA 510(k) record lists Snap40, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package?

The FDA product code for Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package is MSX.

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