DIGITAL 8 W/OTHER NUMERICAL SUFFIXES (1-9, ETC.)— 510(k) K901956

Name: FDA 510(k) clearance K901956
Creator: U.S. Food and Drug Administration
Published: 1990-07-02

Substantially Equivalent

Eigen

FDA 510(k) clearance K901956 for DIGITAL 8 W/OTHER NUMERICAL SUFFIXES (1-9, ETC.), Substantially Equivalent on 1990-07-02. Applicant: Eigen. Device class: 1.

Clearance details

Applicant: Eigen
Product code: Code LMB
Device class: Class 1
Regulation: 21 CFR 892.2010
Advisory panel: Radiology
Date received: 1990-05-01
Decision date: 1990-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nevada City, CA, US

Download summary PDF View on FDA.gov ↗

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