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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Monitoring (W/Wo Alarm)
510(k) Number K260226
Device Name ElintMAX Respiratory Monitor (ElintMAX Monitor A1)
Applicant
Amptron Medical, Inc.
2231 Faraday Ave.,
Suite 130
Carlsbad,  CA  92008
Applicant Contact Nirav Patel
Correspondent
Amptron Medical, Inc.
2231 Faraday Ave.,
Suite 130
Carlsbad,  CA  92008
Correspondent Contact Nirav Patel
Regulation Number868.1850
Classification Product Code
BZK  
Subsequent Product Code
BZQ  
Date Received01/26/2026
Decision Date 09/16/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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