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510(k) Data Aggregation
K Number
K052470Device Name
F1 SERIES DENTAL CHAIRS WITH OPERATIVE UNIT
Manufacturer
SHANGHAI FIMET MEDICAL INSTRUMENT CO., LTD.
Date Cleared
2005-11-01
(54 days)
Product Code
EIA
Regulation Number
872.6640Why did this record match?
Applicant Name (Manufacturer) :
SHANGHAI FIMET MEDICAL INSTRUMENT CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The F I Series Dental Chairs with Operative Unit is intended to supply power to and serve as a base for dental devices and accessories. This product includes a dental chair. The unit is intended for use in the dental clinic/office environment and used by trained dentists and/or dental to thicials and assistants.
Device Description
F1 Series Dental Chairs with Operative Units provide patient comfort and dentists' air and water supplies for dental instruments and procedures. Water pressure: 200~400Kpa. Air pressure: 600~800Kpa. The units can be powered from ~110/220/230V. The chair is motorized. The system is compatible with instruments from various manufacturers with standard fittings.
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