INFINITY MASIMO SET SP02 POD

Oximeter

Draeger Medical Systems, Inc.

The following data is part of a premarket notification filed by Draeger Medical Systems, Inc. with the FDA for Infinity Masimo Set Sp02 Pod.

Pre-market Notification Details

Device IDK061329
510k NumberK061329
Device Name:INFINITY MASIMO SET SP02 POD
ClassificationOximeter
Applicant Draeger Medical Systems, Inc. 16 ELECTRONICS AVE. Danvers,  MA  01923
ContactThomas Mcintosh
CorrespondentThomas Mcintosh
Draeger Medical Systems, Inc. 16 ELECTRONICS AVE. Danvers,  MA  01923
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-05-12
Decision Date2006-07-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04049098050746 K061329 000
04049098050739 K061329 000
04049098004985 K061329 000
04049098004978 K061329 000
04049098004961 K061329 000
04049098004954 K061329 000
04049098004909 K061329 000
04049098004084 K061329 000
04049098003032 K061329 000

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