CADWELL EASYNET OXIMETER MODULE

Oximeter

CADWELL LABORATORIES, INC.

The following data is part of a premarket notification filed by Cadwell Laboratories, Inc. with the FDA for Cadwell Easynet Oximeter Module.

Pre-market Notification Details

Device IDK061706
510k NumberK061706
Device Name:CADWELL EASYNET OXIMETER MODULE
ClassificationOximeter
Applicant CADWELL LABORATORIES, INC. 909 NORTH KELLOGG ST. Kennewick,  WA  99336
ContactChris Bolkan
CorrespondentChris Bolkan
CADWELL LABORATORIES, INC. 909 NORTH KELLOGG ST. Kennewick,  WA  99336
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-06-16
Decision Date2007-03-05

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840067100615 K061706 000
00840067100493 K061706 000
00840067103951 K061706 000

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