Device Classification Name |
stimulator, nerve, peripheral, electric
|
510(k) Number |
K992596 |
Device Name |
TOF-WATCH S |
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 | 08/03/1999 |
Decision Date | 08/30/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|