MEI MAMMOGRAPHY SYS MX-2049— 510(k) K843437

Name: FDA 510(k) clearance K843437
Creator: U.S. Food and Drug Administration
Published: 1984-11-27

Substantially Equivalent

Moti Enterprises, Inc.

FDA 510(k) clearance K843437 for MEI MAMMOGRAPHY SYS MX-2049, Substantially Equivalent on 1984-11-27. Applicant: Moti Enterprises, Inc.. Device class: 2.

Clearance details

Applicant: Moti Enterprises, Inc.
Product code: Code IZH
Device class: Class 2
Regulation: 21 CFR 892.1710
Advisory panel: Radiology
Date received: 1984-09-04
Decision date: 1984-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Detroit, MI, US

Download summary PDF View on FDA.gov ↗

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