DUNLEE FORMAT COLLIMATOR FAMILY— 510(k) K031597

Name: FDA 510(k) clearance K031597
Creator: U.S. Food and Drug Administration
Published: 2003-07-21

Substantially Equivalent

Philips Medical Systems North America Co.

FDA 510(k) clearance K031597 for DUNLEE FORMAT COLLIMATOR FAMILY, Substantially Equivalent on 2003-07-21. Applicant: Philips Medical Systems North America Co.. Device class: 2.

Clearance details

Applicant: Philips Medical Systems North America Co.
Product code: Code IZW
Device class: Class 2
Regulation: 21 CFR 892.1610
Advisory panel: Radiology
Date received: 2003-05-21
Decision date: 2003-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bothell, WA, US

Download summary PDF View on FDA.gov ↗

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