Device Classification Name |
Compressor, Cardiac, External
|
510(k) Number |
K072527 |
Device Name |
AUTOPULSE RESUSCITATION SYSTEM, MODEL 100 |
Applicant |
ZOLL CIRCULATION |
249 HUMBOLDT COURT |
SUNNYVALE,
CA
94089
|
|
Applicant Contact |
MARK PERKINS |
Correspondent |
ZOLL CIRCULATION |
249 HUMBOLDT COURT |
SUNNYVALE,
CA
94089
|
|
Correspondent Contact |
MARK PERKINS |
Regulation Number | 870.5200
|
Classification Product Code |
|
Date Received | 09/07/2007 |
Decision Date | 03/19/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|