Device Classification Name |
automated external defibrillators (non-wearable)
|
510(k) Number |
K033771 |
Device Name |
BIO-DETEK MODIFIED ADULT MULTI-FUNCTION ELECTRODE WITH CONNECTOR |
Applicant |
BIO-DETEK, INC. |
525 NARRAGANSETT PARK DR. |
PAWTUCKET,
RI
02861 -4323
|
|
Applicant Contact |
ROBERT MORSE |
Correspondent |
BIO-DETEK, INC. |
525 NARRAGANSETT PARK DR. |
PAWTUCKET,
RI
02861 -4323
|
|
Correspondent Contact |
ROBERT MORSE |
Regulation Number | 870.5310
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/03/2003 |
Decision Date | 02/27/2004 |
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
|
|
|