Device Classification Name |
oximeter
|
510(k) Number |
K004044 |
Device Name |
HOMMED SENTRY III PATIENT MONITOR SYSTEM |
Applicant |
HOMMED LLC. |
2018 NORTH DURHAM DR. |
HOUSTON,
TX
77008
|
|
Applicant Contact |
TOMMIE J MORGAN |
Correspondent |
HOMMED LLC. |
2018 NORTH DURHAM DR. |
HOUSTON,
TX
77008
|
|
Correspondent Contact |
TOMMIE J MORGAN |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 12/29/2000 |
Decision Date | 03/02/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|