IQQA-CHEST SOFTWARE PACKAGE— 510(k) K042408

Name: FDA 510(k) clearance K042408
Creator: U.S. Food and Drug Administration
Published: 2004-10-08

Substantially Equivalent

Edda Technology, Inc.

FDA 510(k) clearance K042408 for IQQA-CHEST SOFTWARE PACKAGE, Substantially Equivalent on 2004-10-08. Applicant: Edda Technology, Inc.. Device class: 2.

Clearance details

Applicant: Edda Technology, Inc.
Product code: Code OMJ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2004-09-03
Decision date: 2004-10-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deer Field, IL, US

Download summary PDF View on FDA.gov ↗

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