meddevicedb.com FDA Device Reference

SYSTEM 1E PROCESS BIOLOGICAL MONITORING KIT

DEN110002 Class II Post-NSE
Decision Date
2012-03-30
Sponsor / Applicant
STERIS Corporation

Technical Specification

510(k) Submission ID DEN110002
Product Code OVY
Medical Specialty / Panel General Hospital
Regulation Citation 21 CFR 880.6887
Decision Date 2012-03-30
Clearance Pathway Post-NSE

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

SYSTEM 1E PROCESS BIOLOGICAL MONITORING KIT received FDA 510(k) clearance under submission number DEN110002, sponsored by STERIS Corporation. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2012-03-30.

Classification & Regulation

This clearance is catalogued under FDA product code OVY and 21 CFR 880.6887, within the General Hospital review panel as a Class II device.