FDA 510(k)

LifeWindow LW8 Lite

Numéro K : K183687 · 2019-09-25

DemandeurDigicare Biomedical Technology, Inc.

Date de décision2019-09-25

Code produitMWI

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

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

Questions fréquentes

What is the LifeWindow LW8 Lite?

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

When did LifeWindow LW8 Lite receive FDA 510(k) clearance?

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

Who is the listed applicant for LifeWindow LW8 Lite?

The FDA 510(k) record lists Digicare Biomedical Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LifeWindow LW8 Lite?

The FDA product code for LifeWindow LW8 Lite is MWI.

Essais cliniques associés

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Source officielle

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