Device Classification Name |
automated external defibrillators (non-wearable)
|
510(k) Number |
K080421 |
Device Name |
HEART SYNC, MODELS C-100 AND T-100 |
Applicant |
HEART SYNC LLC |
5643 PLYMOUTH ROAD |
ANN ARBOR,
MI
48105
|
|
Applicant Contact |
STEPHEN SHULMAN |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 870.5310
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/15/2008 |
Decision Date | 02/29/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|