MACHNET BILATERAL OPEN BREAST COIL. CATALOG # MICS-GSXX— 510(k) K013985

Name: FDA 510(k) clearance K013985
Creator: U.S. Food and Drug Administration
Published: 2002-02-01

Substantially Equivalent

Machnet BV

FDA 510(k) clearance K013985 for MACHNET BILATERAL OPEN BREAST COIL. CATALOG # MICS-GSXX, Substantially Equivalent on 2002-02-01. Applicant: Machnet BV. Device class: 2.

Clearance details

Applicant: Machnet BV
Product code: Code MOS
Device class: Class 2
Regulation: 21 CFR 892.1000
Advisory panel: Radiology
Date received: 2001-12-03
Decision date: 2002-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deer Field, IL, US

Download summary PDF View on FDA.gov ↗

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