| Device Classification Name |
Transport, Patient, Powered
|
| 510(k) Number |
K033829 |
| Device Name |
BRUNO ELECTRA-RIDE III STAIRWAY ELEVATOR SYSTEM, MODEL CRE-2100 |
| Applicant |
| Bruno Independent Living Aids, Inc. |
| 1780 Executive Dr. |
| P.O. Box 84 |
|
Oconomowoc,
WI
53066
|
|
| Applicant Contact |
RICHARD KELLER |
| Correspondent |
| Bruno Independent Living Aids, Inc. |
| 1780 Executive Dr. |
| P.O. Box 84 |
|
Oconomowoc,
WI
53066
|
|
| Correspondent Contact |
RICHARD KELLER |
| Regulation Number | 890.5150 |
| Classification Product Code |
|
| Date Received | 12/09/2003 |
| Decision Date | 12/29/2003 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Physical Medicine
|
| 510k Review Panel |
Physical Medicine
|
| Statement |
Statement
|
| Type |
Special
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|