IMDX VANR FOR ABBOTT M2000— 510(k) K123753

Name: FDA 510(k) clearance K123753
Creator: U.S. Food and Drug Administration
Published: 2013-07-17

Substantially Equivalent

Intelligent Medical Devices, Inc.

FDA 510(k) clearance K123753 for IMDX VANR FOR ABBOTT M2000, Substantially Equivalent on 2013-07-17. Applicant: Intelligent Medical Devices, Inc.. Device class: 2.

Clearance details

Applicant: Intelligent Medical Devices, Inc.
Product code: Code NIJ
Device class: Class 2
Regulation: 21 CFR 866.1640
Advisory panel: Microbiology
Date received: 2012-12-06
Decision date: 2013-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beverly, MA, 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.