Device Classification Name |
System, Measurement, Blood-Pressure, Non-Invasive
|
510(k) Number |
K040012 |
Device Name |
WELL@HOME SYSTEM |
Applicant |
ZOE MEDICAL, INC. |
460 BOSTON ST. |
TOPSFIELD,
MA
01983 -1223
|
|
Applicant Contact |
STEPHEN STAATS |
Correspondent |
ZOE MEDICAL, INC. |
460 BOSTON ST. |
TOPSFIELD,
MA
01983 -1223
|
|
Correspondent Contact |
STEPHEN STAATS |
Regulation Number | 870.1130
|
Classification Product Code |
|
Date Received | 01/05/2004 |
Decision Date | 04/02/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|