MOBILECARE MONITOR, MODEL 2100— 510(k) K090138

Name: FDA 510(k) clearance K090138
Creator: U.S. Food and Drug Administration
Published: 2009-04-24

Substantially Equivalent

Aframe Digital, Inc.

FDA 510(k) clearance K090138 for MOBILECARE MONITOR, MODEL 2100, Substantially Equivalent on 2009-04-24. Applicant: Aframe Digital, Inc.. Device class: 1.

Clearance details

Applicant: Aframe Digital, Inc.
Product code: Code KMI
Device class: Class 1
Regulation: 21 CFR 880.2400
Advisory panel: General Hospital
Date received: 2009-01-21
Decision date: 2009-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mosely, VA, US

Download summary PDF View on FDA.gov ↗

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