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FDA 510(k)

ClearLink Controlled Phototherapy Equipment

K-Number: K182215 · 2018-10-29

ApplicantDaavlin Distributing Company
Decision Date2018-10-29
Product CodeFTC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ClearLink Controlled Phototherapy Equipment is a medical device manufactured by Daavlin Distributing Company. It received FDA 510(k) clearance on 2018-10-29 under approval number K182215. 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 ClearLink Controlled Phototherapy Equipment?

ClearLink Controlled Phototherapy Equipment is a medical device that received FDA 510(k) clearance on 2018-10-29. It is manufactured by Daavlin Distributing Company. The 510(k) number is K182215.

When was ClearLink Controlled Phototherapy Equipment approved by the FDA?

ClearLink Controlled Phototherapy Equipment received FDA 510(k) clearance on 2018-10-29, under approval number K182215.

What company makes ClearLink Controlled Phototherapy Equipment?

ClearLink Controlled Phototherapy Equipment is manufactured by Daavlin Distributing Company.

What is the FDA product code for ClearLink Controlled Phototherapy Equipment?

The FDA product code for ClearLink Controlled Phototherapy Equipment is FTC.

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Other Devices by Daavlin Distributing Company

K1537493 Series Phototherapy Unit

Related Devices (Code: FTC)

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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.

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