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FDA 510(k)

LifeWindow LW8 Lite

K-Number: K183687 · 2019-09-25

ApplicantDigicare Biomedical Technology, Inc.
Decision Date2019-09-25
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LifeWindow LW8 Lite is a medical device manufactured by Digicare Biomedical Technology, Inc.. It received FDA 510(k) clearance on 2019-09-25 under approval number K183687. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LifeWindow LW8 Lite?

LifeWindow LW8 Lite is a medical device that received FDA 510(k) clearance on 2019-09-25. It is manufactured by Digicare Biomedical Technology, Inc.. The 510(k) number is K183687.

When was LifeWindow LW8 Lite approved by the FDA?

LifeWindow LW8 Lite received FDA 510(k) clearance on 2019-09-25, under approval number K183687.

What company makes LifeWindow LW8 Lite?

LifeWindow LW8 Lite is manufactured by Digicare Biomedical Technology, Inc..

What is the FDA product code for LifeWindow LW8 Lite?

The FDA product code for LifeWindow LW8 Lite is MWI.

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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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