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510(k) K823712

BEL BLOOD LEVEL DETECTOR by R. Scott Bell — Product Code DTW

K823712 is an FDA 510(k) premarket notification submitted by R. Scott Bell for the device "BEL BLOOD LEVEL DETECTOR". The FDA issued a decision of Substantially Equivalent on February 7, 1983. The device falls under product code DTW (Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4340.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 1983
Date Received
December 10, 1982
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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  • K992857 — LEVELSENS - FLEXIBLE, MODEL 201110, LEVELSENS - RIGID, MODEL 201070 (November 10, 1999)
  • K955152 — STOCKERT S3 UPS, LVL CTRL BUBB. DET., DUAL PRESS. CTRL., TEMP MONT., TIMER (February 22, 1996)
  • K910599 — CARDIOPULMONARY BYPASS LEVEL SENSING MONITOR (May 20, 1993)
  • K924354 — STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITOR (February 18, 1993)
  • K915337 — CAPIOX LEVEL ALARM (February 21, 1992)
  • K900910 — COBE AIR EMBOLI PROTECTION SYSTEM (AEPS) (May 22, 1990)
  • K900815 — SARNS 9000 PERFUSION SYSTEM W/ALERT ONLY LEVEL (May 9, 1990)
  • K873206 — MYOCARDIAL TEMP. SENSOR W/TYPE T THERMOCOUPLE (September 30, 1987)

FDA data resources