PROFILE MAMMOGRAPHY SYSTEM (M-PRO)— 510(k) K964576

Name: FDA 510(k) clearance K964576
Creator: U.S. Food and Drug Administration
Published: 1997-01-10

Substantially Equivalent

Bennett X-Ray Corp.

FDA 510(k) clearance K964576 for PROFILE MAMMOGRAPHY SYSTEM (M-PRO), Substantially Equivalent on 1997-01-10. Applicant: Bennett X-Ray Corp.. Device class: 2.

Clearance details

Applicant: Bennett X-Ray Corp.
Product code: Code IZH
Device class: Class 2
Regulation: 21 CFR 892.1710
Advisory panel: Radiology
Date received: 1996-11-14
Decision date: 1997-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Copiague, NY, US

Download summary PDF View on FDA.gov ↗

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