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FDA 510(k)

Saranas Early Bird Bleed Monitoring System

K-Number: K230273 · 2023-05-25

ApplicantSaranas, Inc.
Decision Date2023-05-25
Product CodeQFJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Saranas Early Bird Bleed Monitoring System is a medical device manufactured by Saranas, Inc.. It received FDA 510(k) clearance on 2023-05-25 under approval number K230273. The device is classified under product code QFJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Saranas Early Bird Bleed Monitoring System?

Saranas Early Bird Bleed Monitoring System is a medical device that received FDA 510(k) clearance on 2023-05-25. It is manufactured by Saranas, Inc.. The 510(k) number is K230273.

When was Saranas Early Bird Bleed Monitoring System approved by the FDA?

Saranas Early Bird Bleed Monitoring System received FDA 510(k) clearance on 2023-05-25, under approval number K230273.

What company makes Saranas Early Bird Bleed Monitoring System?

Saranas Early Bird Bleed Monitoring System is manufactured by Saranas, Inc..

What is the FDA product code for Saranas Early Bird Bleed Monitoring System?

The FDA product code for Saranas Early Bird Bleed Monitoring System is QFJ.

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Related PubMed Literature

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Other Devices by Saranas, Inc.

DEN180021Early Bird Bleed Monitoring System

Related Devices (Code: QFJ)

DEN180021Early Bird Bleed Monitoring SystemSaranas, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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