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510(k) Data Aggregation
K Number
K042889Device Name
DYNAMOMETER - MODEL FCE AND MODEL MSC
Manufacturer
AMETEK
Date Cleared
2004-11-16
(28 days)
Product Code
LBB
Regulation Number
888.1240Why did this record match?
Applicant Name (Manufacturer) :
AMETEK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the Chatillon FCE and MSC series dynamometers is for performing manual muscle testing to measure muscle strength. The target population for this product is individuals recovering from physical injury or for sports medicine applications.
Device Description
The Chatillon FCE and MSC series dynamometers are diagnostic devices used for evaluating muscle strength. These instruments are powered by a rechargeable battery (4.8 VDC) which supplied a regulated 2.5 VDC excitation voltage to a strain gauge load cell. The analog output from the load cell (2 mV/V) is then converted to a digital signal that is directly proportional to the applied force. This digital signal is then sent to a microprocessor, which converts the signal to a force value that is stored in memory and/or displayed on the dynamometer graphical display. This design has been used for many years in industrial force measuring instruments and has been also used for physical therapy, occupational medicine and sports medicine. These medical dynamometers are a repackaged version of the industrial force measurement instruments and are designed with special medical attachments that are appropriate for performing manual muscle testing and ergonomic analysis.
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K Number
K943824Device Name
GASEOUS OXYGEN ANALYZER (MODEL S-3A) MODIFICATION
Manufacturer
AMETEK, INC.
Date Cleared
1996-11-01
(914 days)
Product Code
CCL
Regulation Number
868.1720Why did this record match?
Applicant Name (Manufacturer) :
AMETEK, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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