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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessory To Continuous Ventilator (Respirator)
510(k) Number K260051
Device Name CorVision® (91-205-Z0014)
Applicant
CorVent® Medical, Inc.
4837 Amber Valley Pkwy. S Suite #2
Fargo,  ND  58104
Applicant Contact Richard Walsh
Correspondent
CorVent® Medical, Inc.
4837 Amber Valley Pkwy. S Suite #2
Fargo,  ND  58104
Correspondent Contact Amed Ayubi
Regulation Number868.5895
Classification Product Code
MOD  
Date Received01/08/2026
Decision Date 05/12/2026
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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