Device Classification Name |
Ventilator, Continuous, Facility Use
|
510(k) Number |
K213098 |
Device Name |
Panther 5 |
Applicant |
Origin Medical Devices |
23 Corporate Plaza |
Newport Beach,
CA
92660
|
|
Applicant Contact |
Brent Chamblee |
Correspondent |
Arazy Group Consultants Inc. |
3422 Leonardo Lane |
New Smyrna Beach,
FL
32168
|
|
Correspondent Contact |
Ray Kelly |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 09/24/2021 |
Decision Date | 07/20/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|