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510(k) Data Aggregation
K Number
K961779Manufacturer
Date Cleared
1997-06-13
(401 days)
Product Code
Regulation Number
868.1860Type
TraditionalPanel
AnesthesiologyReference & 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.
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