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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rhinoanemometer (Measurement Of Nasal Decongestion)
510(k) Number K221892
Device Name VISIONAIR
Applicant
Pacificmd Biotech, LLC
3195 Saint Rose Pkwy., Suite 210
Henderson,  NV  89052
Applicant Contact Jetmir Palushi
Correspondent
Canyon Labs
6217 S. Bringhurst Blvd., Suite 600
Bluffdale,  UT  84065
Correspondent Contact David M. Locke
Regulation Number868.1800
Classification Product Code
BXQ  
Subsequent Product Code
EOB  
Date Received06/29/2022
Decision Date 10/05/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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