MICRO MAMMO I MAMMOGRAPHY UNIT— 510(k) K871048

Name: FDA 510(k) clearance K871048
Creator: U.S. Food and Drug Administration
Published: 1987-09-01

Substantially Equivalent

Amerasia Import-Export, Inc.

FDA 510(k) clearance K871048 for MICRO MAMMO I MAMMOGRAPHY UNIT, Substantially Equivalent on 1987-09-01. Applicant: Amerasia Import-Export, Inc.. Device class: 2.

Clearance details

Applicant: Amerasia Import-Export, Inc.
Product code: Code IZH
Device class: Class 2
Regulation: 21 CFR 892.1710
Advisory panel: Radiology
Date received: 1987-03-17
Decision date: 1987-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Reno, NV, 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.