Device Classification Name |
electrocardiograph
|
510(k) Number |
K050858 |
Device Name |
ASCENTIA HEARTSTATION ECG MANAGEMENT SYSTEM |
Applicant |
HEARTLAB, INC. |
1 CROSSWIND RD. |
WESTERLY,
RI
02891
|
|
Applicant Contact |
RICHARD PETROCELLI |
Correspondent |
HEARTLAB, INC. |
1 CROSSWIND RD. |
WESTERLY,
RI
02891
|
|
Correspondent Contact |
RICHARD PETROCELLI |
Regulation Number | 870.2340
|
Classification Product Code |
|
Date Received | 04/05/2005 |
Decision Date | 06/29/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|