Device Classification Name |
board, cardiopulmonary
|
510(k) Number |
K191689 |
Device Name |
EleGARD Patient Positioning System |
Applicant |
Minnesota Resuscitation Solutions, d.b.d AdvancedCPR Solutio |
5201 Eden Ave., Suite 300 |
Edina,
MN
55436
|
|
Applicant Contact |
Philip Tetzlaff |
Correspondent |
Minnesota Resuscitation Solutions, d.b.d AdvancedCPR Solutio |
131 Bay Point Dr. NE |
St. Petersburg,
FL
33704
|
|
Correspondent Contact |
Paul Dryden |
Regulation Number | 880.6080
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/25/2019 |
Decision Date | 02/13/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|