| Device Classification Name |
Transducer, Tremor
|
|---|
| 510(k) Number |
K010270 |
|---|
| Device Name |
TREMOROMETER |
|---|
| Applicant |
| FLEXABLE SYSTEMS, INC. |
| 16410 E. TOMSTONE AVE. |
|
FOUNTAIN HILLS,
AZ
85268 -6545
|
|
| Applicant Contact |
ROBERT M TRIPP |
| Correspondent |
| FLEXABLE SYSTEMS, INC. |
| 16410 E. TOMSTONE AVE. |
|
FOUNTAIN HILLS,
AZ
85268 -6545
|
|
| Correspondent Contact |
ROBERT M TRIPP |
| Regulation Number | 882.1950
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 01/29/2001 |
|---|
| Decision Date | 07/25/2001 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
Neurology
|
|---|
| 510k Review Panel |
Neurology
|
|---|
| Summary |
Summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|