SHADOWFORM— 510(k) K964972

Substantially Equivalent

I.Z.I. Medical Products Corp.

FDA 510(k) clearance K964972 for SHADOWFORM, Substantially Equivalent on 1997-05-05. Applicant: I.Z.I. Medical Products Corp.. Device class: 2.

Clearance details

Applicant: I.Z.I. Medical Products Corp.
Product code: Code KPQ
Device class: Class 2
Regulation: 21 CFR 892.5840
Advisory panel: Radiology
Date received: 1996-12-12
Decision date: 1997-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Owings Mills, MD, 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.