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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Network And Communication, Physiological Monitors
510(k) Number K261287
Device Name Digistat Care
Applicant
Ascom Ums Srl Unipersonale
Via Amilcare Ponchielli 29
Scandicci (Fi),  IT 50018
Applicant Contact Tomaso Muzzu
Correspondent
Speed TO Market, Inc.
P.O. Box 3018
Nederland,  CO  80466
Correspondent Contact Thomas Kroenke
Regulation Number870.2300
Classification Product Code
MSX  
Subsequent Product Code
PHC  
Date Received04/20/2026
Decision Date 09/12/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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