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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 the device name listed in this FDA 510(k) record. The listed applicant is Saranas, Inc.. It received FDA 510(k) clearance on 2023-05-25 under 510(k) 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. The listed applicant is Saranas, Inc.. The 510(k) number is K230273.

When did Saranas Early Bird Bleed Monitoring System receive FDA 510(k) clearance?

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

Who is the listed applicant for Saranas Early Bird Bleed Monitoring System?

The FDA 510(k) record lists Saranas, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Official Source

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

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