INTEL-GE CARE INNOVATIONS QUIETCARE— 510(k) K131585

Name: FDA 510(k) clearance K131585
Creator: U.S. Food and Drug Administration
Published: 2013-10-08

Substantially Equivalent

Intel-Ge Care Innovations, LLC

FDA 510(k) clearance K131585 for INTEL-GE CARE INNOVATIONS QUIETCARE, Substantially Equivalent on 2013-10-08. Applicant: Intel-Ge Care Innovations, LLC. Device class: 1.

Clearance details

Applicant: Intel-Ge Care Innovations, LLC
Product code: Code KMI
Device class: Class 1
Regulation: 21 CFR 880.2400
Advisory panel: General Hospital
Date received: 2013-05-31
Decision date: 2013-10-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roseville, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.