DILON 6800 ACELLA (ACELLA)— 510(k) K110384

Name: FDA 510(k) clearance K110384
Creator: U.S. Food and Drug Administration
Published: 2011-05-03

Substantially Equivalent

Dilon Technologies, Inc.

FDA 510(k) clearance K110384 for DILON 6800 ACELLA (ACELLA), Substantially Equivalent on 2011-05-03. Applicant: Dilon Technologies, Inc.. Device class: 1.

Clearance details

Applicant: Dilon Technologies, Inc.
Product code: Code IYX
Device class: Class 1
Regulation: 21 CFR 892.1100
Advisory panel: Radiology
Date received: 2011-02-10
Decision date: 2011-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stillwater, MN, US

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