Device Classification Name |
Automated External Defibrillators (Non-Wearable)
|
510(k) Number |
K121853 |
Device Name |
DDU-2400/2450 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES |
Applicant |
DEFIBTECH, LLC |
741 BOSTON POST ROAD |
GUILFORD,
CT
06437
|
|
Applicant Contact |
Ed Horton |
Correspondent |
DEFIBTECH, LLC |
741 BOSTON POST ROAD |
GUILFORD,
CT
06437
|
|
Correspondent Contact |
Ed Horton |
Regulation Number | 870.5310
|
Classification Product Code |
|
Date Received | 06/25/2012 |
Decision Date | 12/13/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|