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FDA 510(k)

BiliLux

K-Number: K172656 · 2018-05-01

ApplicantDraeger Medical Systems, Inc.
Decision Date2018-05-01
Product CodeLBI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BiliLux is the device name listed in this FDA 510(k) record. The listed applicant is Draeger Medical Systems, Inc.. It received FDA 510(k) clearance on 2018-05-01 under 510(k) number K172656. The device is classified under product code LBI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BiliLux?

BiliLux is a medical device that received FDA 510(k) clearance on 2018-05-01. The listed applicant is Draeger Medical Systems, Inc.. The 510(k) number is K172656.

When did BiliLux receive FDA 510(k) clearance?

BiliLux received FDA 510(k) clearance on 2018-05-01, under 510(k) number K172656.

Who is the listed applicant for BiliLux?

The FDA 510(k) record lists Draeger Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BiliLux?

The FDA product code for BiliLux is LBI.

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Related Devices (Code: LBI)

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.

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Official Source

View on FDA Database →

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

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