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510(k) Data Aggregation
K Number
K993872Device Name
VANNA BATHING SYSTEM
Manufacturer
VANCARE, INC.
Date Cleared
2000-02-16
(93 days)
Product Code
ILJ
Regulation Number
890.5100Why did this record match?
Applicant Name (Manufacturer) :
VANCARE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of this device is the bathing and hygiene of residents/patients in hospitals, nursing homes, or assisted living facilities. The indications for use are the necessity and advisability of a clean and healthy environment in these facilities to prevent the spread of disease.
Device Description
The safety and usefulness of the VÄNNA Bathing System is based on a long history of use of hydro-baths with similar characteristics. As referred to previously the VÄNNA Bathing System uses similar technology and components as other devises already on the market. Technological updates have been used in the VÄNNA Bathing System in the temperature sensor and temperature read-out indicators but these differences enhance the reliability of this devise.
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