Device Classification Name |
Oximeter
|
510(k) Number |
K081572 |
Device Name |
SMARTSIGNS MINPULSE |
Applicant |
HUNTLEIGH HEALTHCARE LTD. |
35 PORTMANMOOR RD. |
CARDIFF, SOUTH GLAMORGAN,
GB
CF24 5HN
|
|
Applicant Contact |
ROBERT MCCARTHY |
Correspondent |
HUNTLEIGH HEALTHCARE LTD. |
35 PORTMANMOOR RD. |
CARDIFF, SOUTH GLAMORGAN,
GB
CF24 5HN
|
|
Correspondent Contact |
ROBERT MCCARTHY |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 06/04/2008 |
Decision Date | 10/01/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|