Linshom Respiratory Monitoring Device (LRMD)— 510(k) K190734

Name: FDA 510(k) clearance K190734
Creator: U.S. Food and Drug Administration
Published: 2020-01-30

Substantially Equivalent

Linshom Management, LLC

FDA 510(k) clearance K190734 for Linshom Respiratory Monitoring Device (LRMD), Substantially Equivalent on 2020-01-30. Applicant: Linshom Management, LLC. Device class: 2.

Clearance details

Applicant: Linshom Management, LLC
Product code: Code BZQ
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 2019-03-21
Decision date: 2020-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ellicott City, MD, US

Download summary PDF View on FDA.gov ↗

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