FDA 510(k) Applications for Medical Device Product Code "DTW"
(Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass)

FDA 510(k) Number Applicant Device Name Decision Date
K900815 3M COMPANY SARNS 9000 PERFUSION SYSTEM W/ALERT ONLY LEVEL 05/09/1990
K781145 3M HEALTH CARE, SARNS MONITOR KITS, BLOOD LEVEL 07/27/1978
K831879 3M HEALTH CARE, SARNS UNIVERSAL LEVEL SENSOR 07/26/1983
K852407 AMERICAN OMNI MEDICAL, INC. SENSOR TAPE CAT. NO. ST-45 10/21/1985
K900910 COBE LABORATORIES, INC. COBE AIR EMBOLI PROTECTION SYSTEM (AEPS) 05/22/1990
K822821 GAMBRO, INC. GAMBRO BLOOD LEVEL DETECTOR LCS 10 10/18/1982
K860076 GAMBRO, INC. GAMBRO ULTRASONIC BLOOD LEVEL DETECTOR ULD 10-200 05/30/1986
K910599 JTL MEDICAL CORP. CARDIOPULMONARY BYPASS LEVEL SENSING MONITOR 05/20/1993
K150530 Medtronic, Inc Level Sensor, Level Sensor Tape 05/08/2015
K823712 R. SCOTT BELL BEL BLOOD LEVEL DETECTOR 02/07/1983
K873206 RESPIRATORY SUPPORT PRODUCTS, INC. MYOCARDIAL TEMP. SENSOR W/TYPE "T" THERMOCOUPLE 09/30/1987
K992857 ROCKY MOUNTAIN RESEARCH, INC. LEVELSENS - FLEXIBLE, MODEL 201110, LEVELSENS - RIGID, MODEL 201070 11/10/1999
K843802 SHILEY, INC. STOCKERT-SHILEY UNIVERSAL LEVEL SENSOR 12/27/1984
K924354 SORIN BIOMEDICA, FIAT, USA, INC. STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITOR 02/18/1993
K041558 STOCKERT INSTRUMENTE GMBH STOCKERTIR PURGE CONTROL (APC) SYSTEM 07/02/2004
K955152 STOECKERT INSTRUMENTE STOCKERT S3 UPS, LVL CTRL BUBB. DET., DUAL PRESS. CTRL., TEMP MONT., TIMER 02/22/1996
K915337 TERUMO MEDICAL CORP. CAPIOX LEVEL ALARM 02/21/1992


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