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INFINITY NELLCOR OXIMAX SMARTPOD, MODEL MS23997

K082888 Class II Special
Decision Date
2008-11-26
Sponsor / Applicant
Draeger Medical Systems, Inc.

Technical Specification

510(k) Submission ID K082888
Product Code DQA
Medical Specialty / Panel Cardiovascular
Regulation Citation 21 CFR 870.2700
Decision Date 2008-11-26
Clearance Pathway Special

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

INFINITY NELLCOR OXIMAX SMARTPOD, MODEL MS23997 received FDA 510(k) clearance under submission number K082888, sponsored by Draeger Medical Systems, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2008-11-26.

Classification & Regulation

This clearance is catalogued under FDA product code DQA and 21 CFR 870.2700, within the Cardiovascular review panel as a Class II device.