Device Classification Name |
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
|
510(k) Number |
K113835 |
Device Name |
DATACAPTOR SYSTEM |
Applicant |
CAPSULE TECH INC. |
300 Brickstone Square |
Suite 203 |
Andover,
MA
01810
|
|
Applicant Contact |
PETER KELLEY |
Correspondent |
CAPSULE TECH INC. |
300 Brickstone Square |
Suite 203 |
Andover,
MA
01810
|
|
Correspondent Contact |
PETER KELLEY |
Regulation Number | 870.2300
|
Classification Product Code |
|
Date Received | 12/27/2011 |
Decision Date | 06/27/2012 |
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
|
|
|