meddevicedb.com FDA Device Reference

MANDOMETER III

DEN070014 Class II Post-NSE
Decision Date
2011-03-31
Sponsor / Applicant
Ab Mando

Technical Specification

510(k) Submission ID DEN070014
Product Code OBV
Medical Specialty / Panel Neurology
Regulation Citation 21 CFR 882.5060
Decision Date 2011-03-31
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

MANDOMETER III received FDA 510(k) clearance under submission number DEN070014, sponsored by Ab Mando. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2011-03-31.

Classification & Regulation

This clearance is catalogued under FDA product code OBV and 21 CFR 882.5060, within the Neurology review panel as a Class II device.