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Comaneci, Comaneci Petit, Comaneci 17

DEN170064 Class II Direct
Decision Date
2019-04-24
Sponsor / Applicant
Rapid-Medical , Ltd.

Technical Specification

510(k) Submission ID DEN170064
Product Code PUU
Medical Specialty / Panel Neurology
Regulation Citation 21 CFR 882.5955
Decision Date 2019-04-24
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

Comaneci, Comaneci Petit, Comaneci 17 received FDA 510(k) clearance under submission number DEN170064, sponsored by Rapid-Medical , Ltd.. The device was reviewed via the Direct premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2019-04-24.

Classification & Regulation

This clearance is catalogued under FDA product code PUU and 21 CFR 882.5955, within the Neurology review panel as a Class II device.