CODONICS EP-1000 MEDICAL COLOR DRY IMAGERS— 510(k) K030690

Name: FDA 510(k) clearance K030690
Creator: U.S. Food and Drug Administration
Published: 2003-04-30

Substantially Equivalent

Codonics, Inc.

FDA 510(k) clearance K030690 for CODONICS EP-1000 MEDICAL COLOR DRY IMAGERS, Substantially Equivalent on 2003-04-30. Applicant: Codonics, Inc.. Device class: 2.

Clearance details

Applicant: Codonics, Inc.
Product code: Code LMC
Device class: Class 2
Regulation: 21 CFR 892.2040
Advisory panel: Radiology
Date received: 2003-03-05
Decision date: 2003-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Middleburg Heights, OH, US

Download summary PDF View on FDA.gov ↗

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