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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Aspiration And Injection, Disposable
510(k) Number K223625
Device Name CapnoSpot™ Pneumothorax Decompression Indicator
Applicant
Pneumeric, Inc.
823 4th Street SW, c/o Johnathon Aho
Rochester,  MN  55902
Applicant Contact Johnathon M.E. Aho
Correspondent
Pneumeric, Inc.
823 4th Street SW, c/o Johnathon Aho
Rochester,  MN  55902
Correspondent Contact Johnathon M.E. Aho
Regulation Number878.4800
Classification Product Code
GAA  
Date Received12/05/2022
Decision Date 03/28/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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