LEAF PATIENT MONITORING SYSTEM— 510(k) K141877

Name: FDA 510(k) clearance K141877
Creator: U.S. Food and Drug Administration
Published: 2014-11-10

Substantially Equivalent

Leaf Healthcare, Inc.

FDA 510(k) clearance K141877 for LEAF PATIENT MONITORING SYSTEM, Substantially Equivalent on 2014-11-10. Applicant: Leaf Healthcare, Inc.. Device class: 1.

Clearance details

Applicant: Leaf Healthcare, Inc.
Product code: Code KMI
Device class: Class 1
Regulation: 21 CFR 880.2400
Advisory panel: General Hospital
Date received: 2014-07-11
Decision date: 2014-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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