FDA.report

510(k) K864408

Device
EMG-1, MOTOR NERVE MONITOR
Applicant
ALGOTEK, INC.
510(k) number
K864408
Product code
IKN  
Decision
Substantially Equivalent (SESE)
Decision date
1987-01-30
Date received
1986-11-10
Regulation
890.1375
Classification name
Electromyograph, Diagnostic
Medical specialty
Physical Medicine
Review panel
Neurology
Device class
2
Clearance type
Traditional
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
MAURIZIO LIVERANI
Address
2464 Embarcadero Way Palo Alto CA US 94303 94303

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

Legacy Summary

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FDA Review

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