FDA 510(k)

M Series Phototherapy Equipment

K-Number: K210881 · 2021-06-22

Decision Date2021-06-22

Product CodeFTC

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

M Series Phototherapy Equipment is a medical device manufactured by Daavlin Distributing Co.. It received FDA 510(k) clearance on 2021-06-22 under approval number K210881. The device is classified under product code FTC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the M Series Phototherapy Equipment?

M Series Phototherapy Equipment is a medical device that received FDA 510(k) clearance on 2021-06-22. It is manufactured by Daavlin Distributing Co.. The 510(k) number is K210881.

When was M Series Phototherapy Equipment approved by the FDA?

M Series Phototherapy Equipment received FDA 510(k) clearance on 2021-06-22, under approval number K210881.

What company makes M Series Phototherapy Equipment?

M Series Phototherapy Equipment is manufactured by Daavlin Distributing Co..

What is the FDA product code for M Series Phototherapy Equipment?

The FDA product code for M Series Phototherapy Equipment is FTC.

Other Devices by Daavlin Distributing Co.

K2125107 Series Phototherapy Device K2208401 Series Phototherapy Equipment K233811DT Controlled Phototherapy Equipment K2303823 Series NeoLux

Related Devices (Code: FTC)

K1537493 Series Phototherapy UnitDaavlin Distributing Company K171702Exciplex308nmClarteis K170489Skylit Phototherapy SystemSkylit Medical K182215ClearLink Controlled Phototherapy EquipmentDaavlin Distributing Company K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd. K173436Luma Light SystemLuma Therapeutics

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.