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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilatory Effort Recorder
510(k) Number K250882
Device Name SANSA HSAT
Applicant
Huxley Medical
1465 Northside Dr. NW
Suite 217
Atlanta,  GA  30318
Applicant Contact Daniel Burnham
Correspondent
Powers Regulatory Consulting
2451 Cumberland Blvd. SE
Suite 3740
Atlanta,  GA  30339
Correspondent Contact Grace Powers
Regulation Number868.2375
Classification Product Code
MNR  
Subsequent Product Codes
BZQ   MWJ  
Date Received03/24/2025
Decision Date 10/29/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT06414447
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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