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510(k) Data Aggregation
K Number
K023465Device Name
KENDRO HERACELL 240 INCUBATOR
Manufacturer
Date Cleared
2003-03-10
(146 days)
Product Code
Regulation Number
884.6120Why did this record match?
Applicant Name (Manufacturer) :
KENDRO LABORATORY PRODUCTS, L.P.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intended use of this incubator is to provide an environment with controlled temperature, CO2 elevated humidity, an automatic decontamination mode, and O2 at suppressed levels, for the development of ova or embryos at or near body temperature.
Device Description
The Kendro HERAcell 240 incubators are bench top or floor standing units. The devices control CO2, temperature, provide elevated humidity, feature a decontamination mode, and control O- at suppressed levels to ensure the proper development of ova or embryos at or near body temperature. The conditions produced by the subject device are an exact simulation of physiological conditions. Controlled parameters and alarin functions are microprocessor controlled. The basic model includes the auto-zero self-balancing CO2 control system, which ensures long term stability of CO2 levels. Each unit is equipped with a water level alarm to remind the user to refill the water reservoir. As with the predicate device the user has the choice of a stainless steel or solid copper inner chamber. Additionally, the user can choose from additional options such as Oxygen control, Infra-Red Sensor, and the roller bottle system. The basic model includes the TC (thermal conductivity) sensor, however the user can choose the Infra-Red Sensor option.
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K Number
K002805Device Name
KENDRO HERACELL CO2 INCUBATOR
Manufacturer
Date Cleared
2000-11-09
(62 days)
Product Code
Regulation Number
884.6120Why did this record match?
Applicant Name (Manufacturer) :
KENDRO LABORATORY PRODUCTS, L.P.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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