FDA.report

510(k) K050162

Device
CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE
Applicant
MEDTRONIC XOMED, INC.
510(k) number
K050162
Product code
ETN  
Decision
Substantially Equivalent (SESE)
Decision date
2005-03-03
Date received
2005-01-25
Regulation
874.1820
Classification name
Stimulator, Nerve
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
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
DAVID S DODD
Address
6743 Southpoint Dr. N. Jacksonville FL US 32216 32216

FDA Registration Numbers

Source Documents

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

Related GUDID Devices

Primary DIBrandCompanyPublished
00763000745868NIM ContactMEDTRONIC XOMED, INC.2023-09-03
00763000745851NIM ContactMEDTRONIC XOMED, INC.2023-09-03
00763000745844NIM ContactMEDTRONIC XOMED, INC.2023-09-03
00643169789579NIM CONTACT®MEDTRONIC XOMED, INC.2016-11-06
00643169789562NIM CONTACT®MEDTRONIC XOMED, INC.2016-11-06
00643169789555NIM CONTACT®MEDTRONIC XOMED, INC.2016-11-06

Legacy Summary

summary

FDA Review

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