Device Classification Name |
Stimulator, Nerve, Battery-Powered
|
510(k) Number |
K883807 |
Device Name |
AXOSTIM |
Applicant |
SINGER MEDICAL PRODUCTS, INC. |
790 MAPLE LN. |
BENSENVILLE,
IL
60106
|
|
Applicant Contact |
JAMES I BECK |
Correspondent |
SINGER MEDICAL PRODUCTS, INC. |
790 MAPLE LN. |
BENSENVILLE,
IL
60106
|
|
Correspondent Contact |
JAMES I BECK |
Regulation Number | 868.2775
|
Classification Product Code |
|
Date Received | 09/08/1988 |
Decision Date | 02/09/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|