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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 K193311
Device Name Aluna
Applicant
Knox Medical Diagnostics, Inc.
345 California Street, Suite 600
San Francisco,  CA  94104
Applicant Contact Charvi Shetty
Correspondent
Acknowledge Regulatory Strategies
2251 San Diego Ave, Suite B-257
San Diego,  CA  92110
Correspondent Contact Pierre Bounaud
Regulation Number868.1860
Classification Product Code
BZH  
Date Received11/29/2019
Decision Date 03/25/2020
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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