Search Results
Found 1 results
510(k) Data Aggregation
K Number
K013703Device Name
SANYO CO2 INCUBATORS, MODELS NOS. MCO-17AC, MCO-17AIC, MCO-20AIC,AND MC0-175M
Manufacturer
Date Cleared
2001-12-14
(36 days)
Product Code
Regulation Number
884.6120Why did this record match?
Applicant Name (Manufacturer) :
SANYO NORTH AMERICA CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
To provide an environment with controlled temperature, CO2 , (other gases), and elevated humidity for the development of ova or embryos at or near body temperature.
Device Description
The devices are microprocessor controlled to regulate temperature, CO2 density, humidity level, alarms, and other parameters. The interior chamber consists of either stainless steel or a copper enriched stainless steel alloy, and housed within an insulated coated steel exterior cabinet. Operational accessories include options for an automatic CO2 cylinder switchover system, CO2 regulator, communication ports, and data acquisition software. Each device is a bench top or floor standing unit and direct line AC powered.
Ask a Question
Ask a specific question about this device
Page 1 of 1