Device Classification Name |
Oximeter, Tissue Saturation
|
510(k) Number |
K073407 |
Device Name |
PACIFICA |
Applicant |
OR-NIM MEDICAL LTD. |
2001 PENNSYLVANIA AVE. NW |
SUITE 950 |
WASHINGTON,
DC
20006
|
|
Applicant Contact |
CAMPBELL HUTTON |
Correspondent |
OR-NIM MEDICAL LTD. |
2001 PENNSYLVANIA AVE. NW |
SUITE 950 |
WASHINGTON,
DC
20006
|
|
Correspondent Contact |
CAMPBELL HUTTON |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 12/04/2007 |
Decision Date | 02/28/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|