| Device Classification Name |
computer, diagnostic, programmable
|
| 510(k) Number |
K001852 |
| FOIA Releasable 510(k) |
K001852
|
| Device Name |
PERIPHERAL ARTERIAL TONOMETER-PAT 1000RD DEVICE |
| Applicant |
| ITAMAR MEDICAL (C.M.) 1997 LTD. |
| P.O.B. 454 |
|
GINOT SHOMRON 44853,
IL
44853
|
|
| Applicant Contact |
AHAVA STEIN |
| Correspondent |
| ITAMAR MEDICAL (C.M.) 1997 LTD. |
| P.O.B. 454 |
|
GINOT SHOMRON 44853,
IL
44853
|
|
| Correspondent Contact |
AHAVA STEIN |
| Regulation Number | 870.1425
|
| Classification Product Code |
|
| Date Received | 06/19/2000 |
| Decision Date | 02/21/2001 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Cardiovascular
|
| 510k Review Panel |
Cardiovascular
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
|
|