| Device Classification Name |
System, Measurement, Blood-Pressure, Non-Invasive
|
| 510(k) Number |
K993938 |
| Device Name |
THE HOMMED SENTRY, MODEL 1 SENTRY |
| Applicant |
| Hommed, LLC |
| 19275 W. Capitol Dr. |
| Suite 200 |
|
Brookfield,
WI
53045
|
|
| Applicant Contact |
HERSCHEL PEDDICORD |
| Correspondent |
| Hommed, LLC |
| 19275 W. Capitol Dr. |
| Suite 200 |
|
Brookfield,
WI
53045
|
|
| Correspondent Contact |
HERSCHEL PEDDICORD |
| Regulation Number | 870.1130 |
| Classification Product Code |
|
| Date Received | 11/19/1999 |
| Decision Date | 03/15/2000 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Cardiovascular
|
| 510k Review Panel |
Cardiovascular
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|