BEACON, MODEL 211060— 510(k) K983948

Name: FDA 510(k) clearance K983948
Creator: U.S. Food and Drug Administration
Published: 1999-04-16

Substantially Equivalent

Philips Medical Systems (Cleveland), Inc.

FDA 510(k) clearance K983948 for BEACON, MODEL 211060, Substantially Equivalent on 1999-04-16. Applicant: Philips Medical Systems (Cleveland), Inc.. Device class: 2.

Clearance details

Applicant: Philips Medical Systems (Cleveland), Inc.
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 1998-11-05
Decision date: 1999-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, US

Download summary PDF View on FDA.gov ↗

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