Device Classification Name |
Compressor, Cardiac, External
|
510(k) Number |
K221700 |
Device Name |
AutoPulse NXT Resuscitation System |
Applicant |
ZOLL Circulation, Inc. |
2000 Ringwood Avenue |
San Jose,
CA
95131
|
|
Applicant Contact |
Brian Robey |
Correspondent |
ZOLL Circulation, Inc. |
2000 Ringwood Avenue |
San Jose,
CA
95131
|
|
Correspondent Contact |
Brian Robey |
Regulation Number | 870.5200
|
Classification Product Code |
|
Date Received | 06/13/2022 |
Decision Date | 03/09/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|