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510(k) K061918

FOLEY CATHETERS WITH TEMPERATURE PROBE by Ge Healthcare — Product Code EYC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 2006
Date Received
July 6, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Upper Urinary Tract
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

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Other clearances for product code EYC

  • K200757 — Foley Catheter with Temperature Sensor (October 15, 2020)
  • K041416 — EXAC-TEMP FOLEY CATHETER AND CLINI-TEMP FOLEY CATHETER (July 2, 2004)
  • K925790 — EXAC-TEMP & CLINI-TEMP FOLEY CATHETER'S (May 17, 1993)
  • K890310 — STERILE FOLEY CATHETER (November 30, 1989)