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510(k) Data Aggregation
K Number
K032526Device Name
BINDER CO2 INCUBATOR SERIE CB
Manufacturer
Date Cleared
2003-08-29
(14 days)
Product Code
Regulation Number
884.6120Why did this record match?
Applicant Name (Manufacturer) :
BINDER GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Incubators series CB provide suitable growth-conditions for NaHCO3 -buffered cell cultures of ova or embryos with controlled temperature at or near 37°C (98.6°F) and carbon-dioxide atmosphere (optional additionally at hyper oxide or hypo oxide atmosphere) at a high humidity. A automatic dry heat decontamination process of the empty incubator, applicable between different loadings assists to avoid contaminations of the cell cultures.
Device Description
BINDER incubators series CB are bench top or floor standing units. There are two different sizes available. One of approximately 5.3 cubic feet inner volume (150 liters) and one with 7.4 cubic feet volume (210 liters). One multi-channel controller with a large area LCD screen controls the growth parameters temperature and inner carbon-dioxide (CO2) concentration and provide elevated humidity. The inner chamber volume is closed against the environment. Optionally the units are equipped with a control channel for Oxygen (O2). Temperature, CO2 concentration (optional also O2 concentration) are microprocessor controlled. Constant and reliable temperatures are achieved by the patented air-jacked heating system. The air-jacket provides highly precise and homogeneous temperatures within the incubator which is ideal for long term culturing. The system has very short recovery times upon door openings. The concentration of CO2 is controlled by a single beam infrared (IR) difference detector. The IR sensor has an auto correction function and is characterized by minimal reaction latencies. The detection system for the optional Oxygen control bases on the amperometric system of a Zirconium-Dioxide (ZrO2) electrode.
The incubator is equipped with a dry-heat decontamination function at 187°C (368.6°F).
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