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510(k) K843802

Device
Stockert-shiley Universal Level Sensor
Applicant
SHILEY, INC.
510(k) number
K843802
Product code
DTW
Decision
Substantially Equivalent (SESE)
Decision date
1984-12-27
Date received
1984-09-27
Regulation
870.4340
Classification name
Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
KAREN SALINAS
Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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510(k), Device, Applicant table
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K924354STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITORSorin Biomedica, Fiat, USA, Inc.1993-02-18
K915337CAPIOX LEVEL ALARMTerumo Medical Corp.1992-02-21
K900910COBE AIR EMBOLI PROTECTION SYSTEM (AEPS)Cobe Laboratories, Inc.1990-05-22
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K873206MYOCARDIAL TEMP. SENSOR W/TYPE T THERMOCOUPLERespiratory Support Products, Inc.1987-09-30
K860076GAMBRO ULTRASONIC BLOOD LEVEL DETECTOR ULD 10-200Gambro, Inc.1986-05-30
K852407SENSOR TAPE CAT. NO. ST-45American Omni Medical, Inc.1985-10-21
K831879UNIVERSAL LEVEL SENSOR3M Health Care, Sarns1983-07-26
K823712BEL BLOOD LEVEL DETECTORR. Scott Bell1983-02-07
K822821GAMBRO BLOOD LEVEL DETECTOR LCS 10Gambro, Inc.1982-10-18