Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 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.

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. 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.

Related Devices (Code: MWI)

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.

K260438Vital Signs Monitor (CLEO2)Infinium Medical, Inc.K253417Masimo Root Monitoring SystemMasimo CorporationK253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark CorporationK253436c-med0 alphaCosinuss GmbHK250135WAVE Clinical Platform (2.0.000)Baxter Healthcare Corp/ Excel MedicalK241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV

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.

↑