Device Classification Name |
calculator, drug dose
|
510(k) Number |
K192841 |
Device Name |
InPen System |
Applicant |
Companion Medical, Inc. |
11011 Via Frontera, Suite D |
San Diego,
CA
92127
|
|
Applicant Contact |
Jasper Benke |
Correspondent |
Companion Medical, Inc. |
11011 Via Frontera, Suite D |
San Diego,
CA
92127
|
|
Correspondent Contact |
Jasper Benke |
Regulation Number | 868.1890
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/03/2019 |
Decision Date | 02/10/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
|
|