Saranas Early Bird Bleed Monitoring System— 510(k) K230273

Name: FDA 510(k) clearance K230273
Creator: U.S. Food and Drug Administration
Published: 2023-05-25

Substantially Equivalent

Saranas, Inc.

FDA 510(k) clearance K230273 for Saranas Early Bird Bleed Monitoring System, Substantially Equivalent on 2023-05-25. Applicant: Saranas, Inc.. Device class: 2.

Clearance details

Applicant: Saranas, Inc.
Product code: Code QFJ
Device class: Class 2
Regulation: 21 CFR 870.1345
Advisory panel: Cardiovascular
Date received: 2023-01-31
Decision date: 2023-05-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

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