| Device Classification Name |
Computer, Diagnostic, Programmable
|
| 510(k) Number |
K023370 |
| Device Name |
CHEETAH I.V.D.S., MODEL 2002P |
| Applicant |
| Cheetah Medical, Inc. |
| 117 Ahuzah St. |
|
Ra'Ananna 43373,
IL
43373
|
|
| Applicant Contact |
ARAVA HACOHEN |
| Correspondent |
| Cheetah Medical, Inc. |
| 117 Ahuzah St. |
|
Ra'Ananna 43373,
IL
43373
|
|
| Correspondent Contact |
ARAVA HACOHEN |
| Regulation Number | 870.1425 |
| Classification Product Code |
|
| Date Received | 10/08/2002 |
| Decision Date | 12/24/2002 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Cardiovascular
|
| 510k Review Panel |
Cardiovascular
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|