FDA.report

510(k) K173113

Device
Medline Disposable Electronic Thermometer Probe Cover
Applicant
Medline Industries, Inc.
510(k) number
K173113
Product code
FLL  
Decision
Substantially Equivalent (SESE)
Decision date
2018-01-17
Date received
2017-09-29
Regulation
880.2910
Classification name
Thermometer, Electronic, Clinical
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Dinah Rincones
Address
Three Lake Dr. Northfiled IL US 60093 60093

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
40193489383950Medline Industries, Inc.MEDLINE INDUSTRIES, INC.2022-08-04
10888277628373MedlineMEDLINE INDUSTRIES, INC.2022-04-15
30888277116522MedlineMEDLINE INDUSTRIES, INC.2022-03-31
00888277116514MedlineMEDLINE INDUSTRIES, INC.2022-03-31
00888277115425MedlineMEDLINE INDUSTRIES, INC.2022-03-31

Legacy Summary

summary

FDA Review

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