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FDA 510(k)

Raycell MK1

K-Number: K181737 · 2019-01-02

Decision Date2019-01-02
Product CodeMOT
DecisionSubstantially Equivalent

Device Summary

Raycell MK1 is a medical device manufactured by Best Theratronics Limited. It received FDA 510(k) clearance on 2019-01-02 under approval number K181737. The device is classified under product code MOT. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Raycell MK1?

Raycell MK1 is a medical device that received FDA 510(k) clearance on 2019-01-02. It is manufactured by Best Theratronics Limited. The 510(k) number is K181737.

When was Raycell MK1 approved by the FDA?

Raycell MK1 received FDA 510(k) clearance on 2019-01-02, under approval number K181737.

What company makes Raycell MK1?

Raycell MK1 is manufactured by Best Theratronics Limited.

What is the FDA product code for Raycell MK1?

The FDA product code for Raycell MK1 is MOT.

Other Devices by Best Theratronics Limited

Related Devices (Code: MOT)

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.