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510(k) K955152

STOCKERT S3 UPS, LVL CTRL BUBB. DET., DUAL PRESS. CTRL., TEMP MONT., TIMER by Stoeckert Instrumente — Product Code DTW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 1996
Date Received
November 13, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4340
Review Panel
CV
Submission Type

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  • K900815 — SARNS 9000 PERFUSION SYSTEM W/ALERT ONLY LEVEL (May 9, 1990)
  • K873206 — MYOCARDIAL TEMP. SENSOR W/TYPE T THERMOCOUPLE (September 30, 1987)
  • K860076 — GAMBRO ULTRASONIC BLOOD LEVEL DETECTOR ULD 10-200 (May 30, 1986)