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FDA 510(k)

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

K-Number: K182543 · 2018-11-14

ApplicantSnap40, Ltd.
Decision Date2018-11-14
Product CodeMSX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Snap40, Ltd.. The 510(k) number is K182543.

When was Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package approved by the FDA?

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 approval number K182543.

What company makes 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 manufactured by Snap40, Ltd..

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.

Related Clinical Trials

Related PubMed Literature

Related Devices (Code: MSX)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.