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Early Bird Bleed Monitoring System

DEN180021 Class II Direct
Decision Date
2019-03-01
Sponsor / Applicant
Saranas, Inc.

Technical Specification

510(k) Submission ID DEN180021
Product Code QFJ
Medical Specialty / Panel Cardiovascular
Regulation Citation 21 CFR 870.1345
Decision Date 2019-03-01
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

Early Bird Bleed Monitoring System received FDA 510(k) clearance under submission number DEN180021, sponsored by Saranas, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2019-03-01.

Classification & Regulation

This clearance is catalogued under FDA product code QFJ and 21 CFR 870.1345, within the Cardiovascular review panel as a Class II device.