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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
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