meddevicedb.com FDA Device Reference

Caption Guidance

DEN190040 Class II Direct
Decision Date
2020-02-07
Sponsor / Applicant
Bay Labs, Inc.

Technical Specification

510(k) Submission ID DEN190040
Product Code QJU
Medical Specialty / Panel Radiology
Regulation Citation 21 CFR 892.2100
Decision Date 2020-02-07
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

Caption Guidance received FDA 510(k) clearance under submission number DEN190040, sponsored by Bay Labs, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2020-02-07.

Classification & Regulation

This clearance is catalogued under FDA product code QJU and 21 CFR 892.2100, within the Radiology review panel as a Class II device.