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510(k) Data Aggregation
K Number
K193311Device Name
Aluna
Manufacturer
Knox Medical Diagnostics, Inc.
Date Cleared
2020-03-25
(117 days)
Product Code
BZH
Regulation Number
868.1860Why did this record match?
Applicant Name (Manufacturer) :
Knox Medical Diagnostics, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Aluna is intended for monitoring FEV1 (Forced exhalation in the first second) and PEF (Peak Expired Flow Rate) for home use. The device is designed for children 5 years of age or older, adolescent and adult subjects. Additionally, the device may be used by clinicians for in-office monitoring.
Device Description
Aluna is a small hand-held peak flow meter that captures lung health information and makes it available through a mobile application. Aluna is intended for monitoring FEV1 (Forced Expiratory Volume in one second) and PEF (Peak Expiratory Flow) for over-the-counter use. Aluna is designed for use by pediatric to adult users. Aluna is not recommended for children under 5 years of age. Additionally, the device may be used by clinicians for in-office monitoring.
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