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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intravascular Bleed Monitor
510(k) Number K230273
Device Name Saranas Early Bird Bleed Monitoring System
Applicant
Saranas Inc.
2450 Holcombe Blvd. Suite X
Houston,  TX  77021
Applicant Contact Odell Roberts
Correspondent
RQM+
2251 San Diego Ave.
Suite B-257
San Diego,  CA  92110
Correspondent Contact Allison Komiyama
Regulation Number870.1345
Classification Product Code
QFJ  
Date Received01/31/2023
Decision Date 05/25/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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