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510(k) K903816

URINE METER FOLEY TRAY WITH TEMPERATURE SENSOR by Respiratory Support Products, Inc. — Product Code EZK

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
October 31, 1990
Date Received
August 20, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Retention Type
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

Other clearances by Respiratory Support Products, Inc.

  • K983862 — CLOUD 1 HUMIDIFICATION SYSTEM (May 24, 1999)
  • K921190 — ADAP-TEMP TEMPERATURE SENSOR ADAPTER (March 9, 1993)
  • K920469 — MYOCARDINAL TEMPERATURE SENSOR WITH TYPE 400 SERIE (September 11, 1992)
  • K921510 — GAS SAMPLING KIT MODIFICATION (June 11, 1992)
  • K913082 — BI-TEMP TEMPERATURE MONITOR,MODEL TM-300D (December 11, 1991)
  • K913083 — BI-TEMP TEMPERATURE MONITOR TM-201D (October 17, 1991)
  • K912280 — BI-TEMP TEMPERATURE MONITOR, MODEL TM-400D (October 17, 1991)
  • K874694 — ADAP-TEMP, MODEL: AT-100 (March 1, 1988)
  • K873472 — MEMBRANE HUMIDIFIER (January 19, 1988)
  • K873205 — TYMPANIC TEMPERATURE SENSOR (January 14, 1988)

Other clearances for product code EZK

  • K911349 — E-Z-EM ENTEROCLYSIS CATHETER SET (November 16, 1992)
  • K770408 — KARAYA GUM POWDER, OSTOMY (March 15, 1977)