JPI INTENSIFYING SCREEN— 510(k) K954161

Name: FDA 510(k) clearance K954161
Creator: U.S. Food and Drug Administration
Published: 1996-02-02

Substantially Equivalent

Jpi Healthcare Co, Ltd.

FDA 510(k) clearance K954161 for JPI INTENSIFYING SCREEN, Substantially Equivalent on 1996-02-02. Applicant: Jpi Healthcare Co, Ltd.. Device class: 1.

Clearance details

Applicant: Jpi Healthcare Co, Ltd.
Product code: Code EAM
Device class: Class 1
Regulation: 21 CFR 892.1960
Advisory panel: Radiology
Date received: 1995-09-05
Decision date: 1996-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bayside, NY, US

Download summary PDF View on FDA.gov ↗

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