Device Classification Name |
Oximeter, Reprocessed
|
510(k) Number |
K080424 |
Device Name |
HYGIA HEALTH SERVICES REPROCESSED LNCS SENSORS, MODELS HHS-1858, HHS-1862, HHS-1860 AND HHS-1861 |
Applicant |
HYGIA HEALTH SERVICES, INC. |
434 INDUSTRIAL LN. |
BIRMINGHAM,
AL
35211
|
|
Applicant Contact |
JEROME JAMES |
Correspondent |
HYGIA HEALTH SERVICES, INC. |
434 INDUSTRIAL LN. |
BIRMINGHAM,
AL
35211
|
|
Correspondent Contact |
JEROME JAMES |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 02/15/2008 |
Decision Date | 05/28/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|