Device Classification Name |
Stimulator, Nerve, Peripheral, Electric
|
510(k) Number |
K972698 |
Device Name |
TOF-WATCH |
Applicant |
ORGANON TEKNIKA CORP. |
100 AKZO AVE. |
DURHAM,
NC
27712
|
|
Applicant Contact |
REBECCA A RIVAS |
Correspondent |
ORGANON TEKNIKA CORP. |
100 AKZO AVE. |
DURHAM,
NC
27712
|
|
Correspondent Contact |
REBECCA A RIVAS |
Regulation Number | 868.2775
|
Classification Product Code |
|
Date Received | 07/18/1997 |
Decision Date | 12/16/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|