FDA.report

510(k) K990793

Device
ACCUGUIDE MUSCLE INJECTION MONITOR
Applicant
MEDTRONIC XOMED
510(k) number
K990793
Product code
GXZ  
Decision
Substantially Equivalent (SESE)
Decision date
1999-10-22
Date received
1999-03-10
Regulation
882.1350
Classification name
Electrode, Needle
Medical specialty
Neurology
Review panel
Neurology
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 TIMLIN
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
00613994161635Accuguide®MEDTRONIC XOMED, INC.2016-04-29
00643169294332NAMEDTRONIC XOMED, INC.2016-04-29
00643169294325NAMEDTRONIC XOMED, INC.2016-04-29
20643169345007ACCUGUIDE®MEDTRONIC XOMED, INC.2016-04-22
20643169344994ACCUGUIDE®MEDTRONIC XOMED, INC.2016-04-22

Legacy Summary

summary

FDA Review

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