ISO-MAMMO— 510(k) K860129

Name: FDA 510(k) clearance K860129
Creator: U.S. Food and Drug Administration
Published: 1986-03-06

Substantially Equivalent

Philips Medical Systems (Cleveland), Inc.

FDA 510(k) clearance K860129 for ISO-MAMMO, Substantially Equivalent on 1986-03-06. Applicant: Philips Medical Systems (Cleveland), Inc.. Device class: 2.

Clearance details

Applicant: Philips Medical Systems (Cleveland), Inc.
Product code: Code IZH
Device class: Class 2
Regulation: 21 CFR 892.1710
Advisory panel: Radiology
Date received: 1986-01-14
Decision date: 1986-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Highland Heights, OH, 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.