MR GUIDED PROCEDURES (MRGP) BASIC PACKAGE— 510(k) K983342

Name: FDA 510(k) clearance K983342
Creator: U.S. Food and Drug Administration
Published: 1998-12-21

Substantially Equivalent

Philips Medical Systems (Cleveland), Inc.

FDA 510(k) clearance K983342 for MR GUIDED PROCEDURES (MRGP) BASIC PACKAGE, Substantially Equivalent on 1998-12-21. Applicant: Philips Medical Systems (Cleveland), Inc.. Device class: 2.

Clearance details

Applicant: Philips Medical Systems (Cleveland), Inc.
Product code: Code LHN
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 1998-09-23
Decision date: 1998-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, 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.