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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Meter, Peak Flow, Spirometry
510(k) Number K232588
Device Name Aluna 2
Applicant
Knox Medical Diagnostics
650 California St., Floor 7
San Francisco,  CA  94108
Applicant Contact Michael Raftery
Correspondent
RQM+
2790 Mosside Blvd., Suite 800
Monroeville,,  PA  15146
Correspondent Contact Allison Komiyama
Regulation Number868.1860
Classification Product Code
BZH  
Date Received08/25/2023
Decision Date 11/25/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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