HFO SHOULDER COIL— 510(k) K080120

Name: FDA 510(k) clearance K080120
Creator: U.S. Food and Drug Administration
Published: 2008-03-10

Substantially Equivalent

Philips Medical Systems MR Finland

FDA 510(k) clearance K080120 for HFO SHOULDER COIL, Substantially Equivalent on 2008-03-10. Applicant: Philips Medical Systems MR Finland. Device class: 2.

Clearance details

Applicant: Philips Medical Systems MR Finland
Product code: Code MOS
Device class: Class 2
Regulation: 21 CFR 892.1000
Advisory panel: Radiology
Date received: 2008-01-17
Decision date: 2008-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, US

Download summary PDF View on FDA.gov ↗

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