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510(k) Data Aggregation
K Number
K082899Device Name
DYNAMIPEAK PEAK FLOW METER
Manufacturer
Date Cleared
2009-03-10
(161 days)
Product Code
Regulation Number
868.1860Why did this record match?
Applicant Name (Manufacturer) :
DYNAMITECH MEDICAL, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The DynamiPeak™ Peak Flow Meter is designed as a single-patient use device to measure the Peak Expiratory Flow Rate (PEFR). The device is intended for use by children to adults.
Device Description
The DynamiPeak™ Peak Flow Meter is a simple mechanical device that responds to and indicates the peak expiratory flow rate (PEFR) generated by the user during a forced exhalation maneuver. The inlet of the device is placed into the user's mouth after which the maximum rate at exhalation is attempted from nearly full lungs. As this forced exhalation commences, and internal piston extends a spring as it reacts to an internal pressure spike. An indicator is pushed by the moving piston and remains at the maximum displacement position of the piston after the maneuver is terminated. This position corresponds to the PEFR and is quantified in liters per minute by reading a scale next to the indicator. The piston displacement function is logarithmic, thereby providing greater resolution of the scale at lower PEFR readings.
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