Device Classification Name |
automated external defibrillators (non-wearable)
|
510(k) Number |
K013896 |
Device Name |
SENTRY SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR; EXTERNAL DEFIBRILLATION PADS (ELECTRODES) DDP-100; BATTERY PACK 1200MAH; BA |
Applicant |
DEFIBTECH, LLC |
1200 BOSTON POST RD. |
SUITE 207 |
GUILFORD,
CT
06437
|
|
Applicant Contact |
GINTARAS VAISNYS |
Correspondent |
DEFIBTECH, LLC |
1200 BOSTON POST RD. |
SUITE 207 |
GUILFORD,
CT
06437
|
|
Correspondent Contact |
GINTARAS VAISNYS |
Regulation Number | 870.5310
|
Classification Product Code |
|
Date Received | 11/23/2001 |
Decision Date | 06/19/2002 |
Decision |
SE SUBJECT TO TRACKING REG
(ST) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|