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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
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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