FOLEY CATHETERS WITH TEMPERATURE PROBE— 510(k) K061918

Name: FDA 510(k) clearance K061918
Creator: U.S. Food and Drug Administration
Published: 2006-08-18

Substantially Equivalent

GE Healthcare

FDA 510(k) clearance K061918 for FOLEY CATHETERS WITH TEMPERATURE PROBE, Substantially Equivalent on 2006-08-18. Applicant: GE Healthcare. Device class: 2.

Clearance details

Applicant: GE Healthcare
Product code: Code EYC
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2006-07-06
Decision date: 2006-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Needham, MA, US

Download summary PDF View on FDA.gov ↗

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