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510(k) Data Aggregation
K Number
K101988Device Name
HEAL FORCE CO2 INCUBATOR
Manufacturer
Date Cleared
2011-02-08
(209 days)
Product Code
Regulation Number
884.6120Why did this record match?
Applicant Name (Manufacturer) :
SHANGHAI LISHEN SCIENTIFIC EQUIPMENT CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
For Models HF90, HF240, the intended use of these incubators is to provide an environment with controlled temperature, CO2 elevated humidity, and an automatic disinfection mode, for the development of ova or embryos at or near body temperature.
Device Description
The HEAL FORCE CO2 Incubator is a piece of assisted reproductive laboratory equipment used for incubation of ova and embryos.
Structure:
- The outer casing is made of electrolytically galvanized steel sheet and lacquered white (RAL 9002).
- The control elements are made of plastic.
- The inner casing is made of stainless steel.
Internal Fittings:
- The pullout shelves are tilt-proof and adjustable over a height of 50 mm. Removal of shelves, carrier requires no tools, and they can be taken out together at a time.
Heating System:
- Large-surface heating cables are arranged on the outside of the inner casing, to heat the interior space. The heating cables are placed beneath the water reservoir, on the ceiling, on the upper part of the rear wall and in front of the outer door.
- When the outer door is heated, condensation will not precipitate on the glass door. Therefore, the interior remains clearly visible in spite of the prevailing high humidity. Condensation may be formed if the outer door is left open for some time.
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