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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tracheal (W/Wo Connector)
510(k) Number K253437
Device Name Spiro-VISTA
Applicant
Spiro Robotics
22320 Foothill Blvd.
Suite 250
Hayward,  CA  94541
Applicant Contact Jackie Dulken
Correspondent
Spiro Robotics
22320 Foothill Blvd.
Suite 250
Hayward,  CA  94541
Correspondent Contact Jackie Dulken
Regulation Number868.5730
Classification Product Code
BTR  
Date Received10/01/2025
Decision Date 06/12/2026
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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