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510(k) K010382

Device
100 SERIES OXYGEN ANALYZER, MODELS 1000-E AND 1000-I
Applicant
SENSIDYNE, INC.
510(k) number
K010382
Product code
CCL  
Decision
Substantially Equivalent (SESE)
Decision date
2001-03-01
Date received
2001-02-08
Regulation
868.1720
Classification name
Analyzer, Gas, Oxygen, Gaseous-phase
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
GEORGE MASON
Address
16333 Bay Vista Dr. Clearwater FL US 33760 33760

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code CCL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251245OxyMinder Pro (10310)Bio-Med Device, Inc.2025-08-11
K250002Smart Check O2 (MA0236)Life Spark Medical, LLC2025-04-24
K221734Maxtec MaxO2 ME+pMaxtec, LLC2023-04-01
K213933Percent Oxygen SensorsCareox, LLC2022-08-19
K213948OxyMinderBio-Med Devices, Inc.2022-03-17
K173807Accu O2 Oxygen AnalyzerPrecision Medical, Inc.2018-05-02
K153659MaxO2MEMaxtec, LLC2016-06-10
K123195CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIESGE Healthcare Finland Oy2013-02-28
K122290ENVITEC MYSIGN O OXYGEN MEASURING DEVICEEnvitec-Wismar GmbH2013-01-23
K112402ULTRAMAXO2 OXYGEN ANALYERMaxtec, LLC2011-12-14
K082655ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106Envitec-Wismar GmbH2008-11-25
K072469DIGIFLO CONCENTRATOR ANALYZERDigiflo, Inc.2008-01-03
K063096PRECISION OXYGEN MONITORPrecision Medical, Inc.2007-02-27
K063488MAXO2 CUMaxtec, Inc.2007-02-22
K053407OXYGEN ANALYZER, MODELS AII 20000A, AII 2000HC, AII 2000MAnalytical Industries, Inc.2006-04-05

Legacy Summary#

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FDA Review#

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