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K Number
K961779
Device Name
MINI-BELL PEAK FLOW METER/LOW RANGE MODEL PEAK FLOW METER
Manufacturer
AVION MEDICAL PRODUCTS, INC.
Date Cleared
1997-06-13

(401 days)

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

Measures Peak Expiratory Flow Rate (PEFR) for people who have respiratory conditions such as asthma.

Device Description

Mini-Bell Peak Flow Meter/Low Range Model Peak Flow Meter

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a Mini-Bell Peak Flow Meter. It primarily focuses on regulatory approval and does NOT contain information about acceptance criteria or a study proving the device meets those criteria. Therefore, I cannot extract the requested information from this document.

§ 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).