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510(k) K922821

YSI MODELS 4700 FOLEY CATHETER TEMPERATURE PROBES by Yellow Springs Instrument Co., Inc. — Product Code EZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 1992
Date Received
June 11, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Retention Type, Balloon
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Yellow Springs Instrument Co., Inc.

  • K962070 — YSI 400 SERIES ATUOCLAVABLE REUSABLE TEMPERATURE PROBE (July 19, 1996)
  • K922007 — YSI MODEL 441A AIRWAY TEMPERATURE PROBE (November 4, 1992)
  • K910633 — YSI MODEL 1500 BLOOD GLUCOSE ANALYZER (April 12, 1991)
  • K910718 — YSI PRECISION 4000 THERMOMETER (April 9, 1991)
  • K901131 — YSI MODEL 1500 SPORT L-LACTATE ANALYZER (August 27, 1990)
  • K893409 — YSI MODELS 4400 & 4700 ESOPHAGEAL STETHOSCOPE TEMP (July 20, 1989)
  • K891480 — YSI MODEL 2300 STAT GLUCOSE AND L-LACTATE ANALYZER (May 22, 1989)
  • K883793 — DISPOSABLE TEMPERATURE PROBES (SEVERAL MODELS) (November 21, 1988)
  • K865012 — YSI MODEL 801 (March 4, 1987)
  • K853551 — YSI MODEL 790 TELE-THERMOMETER (September 19, 1985)

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