| Device Classification Name |
System, X-Ray, Mobile
|
| 510(k) Number |
K955095 |
| Device Name |
SIERRA BATTERY SEALED LEAD ACID BATTERY SYSTEM |
| Applicant |
| Sierra Battery, Inc. |
| 340 Western Rd. |
| Suite #1 |
|
Reno,
NV
89506
|
|
| Applicant Contact |
RICHARD T DIEHL |
| Correspondent |
| Sierra Battery, Inc. |
| 340 Western Rd. |
| Suite #1 |
|
Reno,
NV
89506
|
|
| Correspondent Contact |
RICHARD T DIEHL |
| Regulation Number | 892.1720 |
| Classification Product Code |
|
| Date Received | 11/07/1995 |
| Decision Date | 12/21/1995 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Radiology
|
| 510k Review Panel |
Radiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|