Device Classification Name |
Stimulator, Nerve, Peripheral, Electric
|
510(k) Number |
K955026 |
Device Name |
AS/3 NMT MODULE |
Applicant |
DATEX MEDICAL INSTRUMENTATION, INC. |
2 HIGHWOOD DR. |
TEWKSBURY,
MA
01876
|
|
Applicant Contact |
JOEL KENT |
Correspondent |
DATEX MEDICAL INSTRUMENTATION, INC. |
2 HIGHWOOD DR. |
TEWKSBURY,
MA
01876
|
|
Correspondent Contact |
JOEL KENT |
Regulation Number | 868.2775
|
Classification Product Code |
|
Date Received | 11/02/1995 |
Decision Date | 04/28/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|