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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sleeve, Limb, Compressible
510(k) Number K251086
Device Name PnueAira (PNCU-01)
Applicant
Biotab, LLC
11701 Borman Dr.
Suite 107
St. Louis,  MO  63146
Applicant Contact Evan Hall
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number870.5800
Classification Product Code
JOW  
Date Received04/09/2025
Decision Date 08/18/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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