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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
510(k) Number K240937
Device Name AIM (N/A)
Applicant
Inventeur, LLC
16192 Coastal Hwy.
Lewes,  DE  19958
Applicant Contact Tariq Chaudhry
Correspondent
ProMedic Consulting, LLC
131 Bay Pt. Dr. NE
St. Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number868.1400
Classification Product Code
CCK  
Subsequent Product Codes
CAT   MNK  
Date Received04/05/2024
Decision Date 12/16/2024
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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