Temperature Probe, Affinity Temperature Probe

Thermometer, Electronic, Clinical

Medtronic, Inc.

The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Temperature Probe, Affinity Temperature Probe.

Pre-market Notification Details

Device IDK160091
510k NumberK160091
Device Name:Temperature Probe, Affinity Temperature Probe
ClassificationThermometer, Electronic, Clinical
Applicant Medtronic, Inc. 7611 Northland Dr. Brooklyn Park,  MN  55428
ContactChoua Thao
CorrespondentChoua Thao
Medtronic, Inc. 7611 Northland Dr. Brooklyn Park,  MN  55428
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-01-15
Decision Date2016-05-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169778191 K160091 000
00643169778184 K160091 000
00643169778177 K160091 000
00763000219628 K160091 000
00763000219635 K160091 000
00763000219642 K160091 000
00763000445744 K160091 000
00763000445737 K160091 000
00763000445720 K160091 000

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