DELTA 16— 510(k) K955411

Substantially Equivalent

Instrumentarium Imaging, Inc.

FDA 510(k) clearance K955411 for DELTA 16, Substantially Equivalent on 1996-03-21. Applicant: Instrumentarium Imaging, Inc.. Device class: 2.

Clearance details

Applicant: Instrumentarium Imaging, Inc.
Product code: Code IZH
Device class: Class 2
Regulation: 21 CFR 892.1710
Advisory panel: Radiology
Date received: 1995-11-27
Decision date: 1996-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tuusula, Finland, FI

Download summary PDF View on FDA.gov ↗

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More clearances from Instrumentarium Imaging, Inc.

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Data sourced from openFDA. This site is unofficial and independent of the FDA.