FDA.report

510(k) K905035

Device
AXOSTIM NERVE STIMULATOR, MODIFICATION
Applicant
SINGER MEDICAL PRODUCTS, INC.
510(k) number
K905035
Product code
ETN  
Decision
Substantially Equivalent (SESE)
Decision date
1991-04-19
Date received
1990-10-25
Regulation
874.1820
Classification name
Stimulator, Nerve
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
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
DEBORAH L SINGER
Address
790 Maple Ln. Bensenville IL US 60106 60106

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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