OXIMAX SOFTCARE SENSORS, MODELS SC-A, SC-PR, SC-NEO, SC-N

Oximeter

NELLCOR PURITAN BENNETT, INC.

The following data is part of a premarket notification filed by Nellcor Puritan Bennett, Inc. with the FDA for Oximax Softcare Sensors, Models Sc-a, Sc-pr, Sc-neo, Sc-n.

Pre-market Notification Details

Device IDK030930
510k NumberK030930
Device Name:OXIMAX SOFTCARE SENSORS, MODELS SC-A, SC-PR, SC-NEO, SC-N
ClassificationOximeter
Applicant NELLCOR PURITAN BENNETT, INC. 4280 HACIENDA DR. Pleasanton,  CA  94588 -2719
ContactGina To
CorrespondentGina To
NELLCOR PURITAN BENNETT, INC. 4280 HACIENDA DR. Pleasanton,  CA  94588 -2719
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-03-25
Decision Date2003-05-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10884522042611 K030930 000
10884522042451 K030930 000
10884522042437 K030930 000
20884522042557 K030930 000
20884522042830 K030930 000

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