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K Number
K955262
Device Name
TRUZONE PEAK FLOW METER
Manufacturer
MONAGHAN MEDICAL CORP.
Date Cleared
1996-03-07

(114 days)

Product Code
BZH
Regulation Number
868.1860
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Not Found

Device Description

The Truzone 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. forced As this exhalation commences an internal piston extends a spring as reaction to an internal pressure spike. An indicator is pushed by the moving piston and remains the maximum displacement position of the piston at maneuver is terminated. This position the after corresponds to the PEFR and is quantified in liters per minute by reading a scale next to the indicator. piston displacement function is logarithmic The thereby providing greater resolution of scale at lower PEFR readings.

The TruZone Peak Flow Meter is identical in form and function to the TruZone Peak Flow Meter as described in its 510(k) #926307 except for the addition of a separate package of Colorione tapes as an accessory to the TruZone Peak Flow Meter. The essence of the modification to this 510 (k) is adding the package for sale to aforementioned accessory physicians.

AI/ML Overview

This K955262 submission is for a medical device called the TruZone Peak Flow Meter. However, the provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria.

The submission primarily focuses on:

  • Identification of the device: TruZone Peak Flow Meter.
  • Description of its function: A simple mechanical device that measures Peak Expiratory Flow Rate (PEFR).
  • Comparison to a legally marketed predicate device: TruZone Peak Flow Meter (K926307).
  • The nature of the current modification: The addition of a separate package of Colorzone tapes as an accessory.

Therefore, I cannot provide a table of acceptance criteria or details about a study as requested, because that information is not present in the given text. The provided text is a 510(k) summary, which often focuses on device description and substantial equivalence to a predicate device, rather than detailed performance study results and acceptance criteria.

§ 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).