Device Classification Name |
stimulator, nerve, ac-powered
|
510(k) Number |
K002677 |
Device Name |
NUVASIVE INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM |
Applicant |
NUVASIVE, INC. |
10065 OLD GROVE RD. |
SAN DIEGO,
CA
92131
|
|
Applicant Contact |
R. STEPHEN REITZLER |
Correspondent |
NUVASIVE, INC. |
10065 OLD GROVE RD. |
SAN DIEGO,
CA
92131
|
|
Correspondent Contact |
R. STEPHEN REITZLER |
Regulation Number | 868.2775
|
Classification Product Code |
|
Date Received | 08/28/2000 |
Decision Date | 11/13/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|