| 510(k) Number |
K850388 |
| Device Name |
ITI 200 ELECTRIC MOTOR DRIVE, UNIV.-WHEELCHAIR ACC |
| Applicant |
| Instrument Technology, Inc. |
| 1961 Old Middlefield Way |
|
Mountain View,
CA
94043
|
|
| Applicant Contact |
ROBERT TETRAULT |
| Correspondent |
| Instrument Technology, Inc. |
| 1961 Old Middlefield Way |
|
Mountain View,
CA
94043
|
|
| Correspondent Contact |
ROBERT TETRAULT |
| Date Received | 02/01/1985 |
| Decision Date | 04/25/1985 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Physical Medicine
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|