(88 days)
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The TruPeak Peak Flow Meter is a simple mechanical that responds to and indicates the Peak device Expiratory Flow Rate (PEFR) generated by the user during a forced exhalation maneuver. inlet of the device is placed into the user 's The mouth after which the maximum rate at exhalation is attempted from nearly full lungs. As this forced commences an internal piston extends exhalation spring as reaction to an internal pressure spike. An indicator is pushed by the moving piston and remains position of the the maximum displacement piston at maneuver is terminated. This position after the corresponds to the PEFR and is quantified in liters per minute by reading a scale next to the indicator. displacement function is logarithmic The piston thereby providing greater resolution of scale at lower PEFR readings.
This K963095 document describes a medical device, the TruPeak Peak Flow Meter, which is a simple mechanical device used to measure Peak Expiratory Flow Rate (PEFR). However, this document is a 510(k) Summary from 1996 and does not contain the acceptance criteria or details of a study demonstrating device performance as requested.
The 510(k) summary primarily focuses on:
- Identifying the device and its manufacturer.
- Classifying the device.
- Establishing substantial equivalence to a previously cleared device (TruPeak Peak Flow Meter, 510(k) #955234).
- Briefly describing the device's function.
- Noting that the current device is identical to the predicate except for changes in component dimensions to conform to the November 1994 ATS Standards update.
Therefore, I cannot provide the requested information from this document. The document simply states conformity to ATS standards, but does not provide the performance data or the study details.
§ 868.1860 Peak-flow meter for spirometry.
(a)
Identification. A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate.(b)
Classification. Class II (performance standards).