meddevicedb.com FDA Device Reference

CipherOx CRI Tablet

DEN160020 Class II Direct
Decision Date
2016-12-21
Sponsor / Applicant
Flashback Technologies, Inc.

Technical Specification

510(k) Submission ID DEN160020
Product Code PPW
Medical Specialty / Panel Cardiovascular
Regulation Citation 21 CFR 870.2200
Decision Date 2016-12-21
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

CipherOx CRI Tablet received FDA 510(k) clearance under submission number DEN160020, sponsored by Flashback Technologies, 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 2016-12-21.

Classification & Regulation

This clearance is catalogued under FDA product code PPW and 21 CFR 870.2200, within the Cardiovascular review panel as a Class II device.