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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 K240285
Device Name Huxley SANSA Home Sleep Apnea Test (1000-00)
Applicant
Huxley Medical
1465 Northside Dr.
Suite 217
Atlanta,  GA  30318
Applicant Contact Brennan Torstrick
Correspondent
Powers Regulatory Consulting
2451 Cumberland Pkwy. SE, Suite 3740
Atlanta,  GA  30339
Correspondent Contact Grace Powers
Regulation Number868.2375
Classification Product Code
MNR  
Subsequent Product Code
BZQ  
Date Received02/01/2024
Decision Date 07/15/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Clinical Trials NCT06070389
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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