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510(k) K822821

Device
GAMBRO BLOOD LEVEL DETECTOR LCS 10
Applicant
GAMBRO, INC.
510(k) number
K822821
Product code
DTW  
Decision
Substantially Equivalent (SESE)
Decision date
1982-10-18
Date received
1982-09-20
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#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DTW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K150530Level Sensor, Level Sensor TapeMedtronic, Inc.2015-05-08
K041558STOCKERTIR PURGE CONTROL (APC) SYSTEMStockert Instrumente GmbH2004-07-02
K992857LEVELSENS - FLEXIBLE, MODEL 201110, LEVELSENS - RIGID, MODEL 201070Rocky Mountain Research, Inc.1999-11-10
K955152STOCKERT S3 UPS, LVL CTRL BUBB. DET., DUAL PRESS. CTRL., TEMP MONT., TIMERStoeckert Instrumente1996-02-22
K910599CARDIOPULMONARY BYPASS LEVEL SENSING MONITORJtl Medical Corp.1993-05-20
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
K900815SARNS 9000 PERFUSION SYSTEM W/ALERT ONLY LEVEL3M Company1990-05-09
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
K843802STOCKERT-SHILEY UNIVERSAL LEVEL SENSORShiley, Inc.1984-12-27
K831879UNIVERSAL LEVEL SENSOR3M Health Care, Sarns1983-07-26
K823712BEL BLOOD LEVEL DETECTORR. Scott Bell1983-02-07

Legacy Summary#

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FDA Review#

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