MULTIPLE ED1600 SERIES RADIATION SHIELDS— 510(k) K944772

Name: FDA 510(k) clearance K944772
Creator: U.S. Food and Drug Administration
Published: 1994-10-20

Substantially Equivalent

Image Diagnostics, Inc.

FDA 510(k) clearance K944772 for MULTIPLE ED1600 SERIES RADIATION SHIELDS, Substantially Equivalent on 1994-10-20. Applicant: Image Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Image Diagnostics, Inc.
Product code: Code EAK
Device class: Class 1
Regulation: 21 CFR 892.6500
Advisory panel: Radiology
Date received: 1994-09-27
Decision date: 1994-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sterling, 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.