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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 the device name listed in this FDA 510(k) record. The listed applicant is Best Theratronics Limited. It received FDA 510(k) clearance on 2019-01-02 under 510(k) 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. The listed applicant is Best Theratronics Limited. The 510(k) number is K181737.

When did Raycell MK1 receive FDA 510(k) clearance?

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

Who is the listed applicant for Raycell MK1?

The FDA 510(k) record lists Best Theratronics Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Raycell MK1?

The FDA product code for Raycell MK1 is MOT.

Other records listing Best Theratronics Limited as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: MOT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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