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510(k) K873448

FOLEY CATHETER TEMPERATURE SENSOR by Respiratory Support Products, Inc. — Product Code KOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 1987
Date Received
August 26, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Urological
Device Class
Class II
Regulation Number
876.5130
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)
  • K903816 — URINE METER FOLEY TRAY WITH TEMPERATURE SENSOR (October 31, 1990)
  • K874694 — ADAP-TEMP, MODEL: AT-100 (March 1, 1988)
  • K873472 — MEMBRANE HUMIDIFIER (January 19, 1988)

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