meddevicedb.com FDA Device Reference

FETAL PILLOW

DEN150053 Class II Direct
Decision Date
2017-07-27
Sponsor / Applicant
Safe Obstetric Systems, Ltd.

Technical Specification

510(k) Submission ID DEN150053
Product Code PWB
Medical Specialty / Panel Obstetrics/Gynecology
Regulation Citation 21 CFR 884.4350
Decision Date 2017-07-27
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

FETAL PILLOW received FDA 510(k) clearance under submission number DEN150053, sponsored by Safe Obstetric Systems, Ltd.. The device was reviewed via the Direct premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2017-07-27.

Classification & Regulation

This clearance is catalogued under FDA product code PWB and 21 CFR 884.4350, within the Obstetrics/Gynecology review panel as a Class II device.