Device Classification Name |
amplifier and signal conditioner, transducer signal
|
510(k) Number |
K172216 |
Device Name |
ACIST RXi Mini System |
Applicant |
ACIST Medical Systems, Inc. |
7905 Fuller Road |
Eden Prairie,
MN
55344
|
|
Applicant Contact |
Amber Luker |
Correspondent |
ACIST Medical Systems, Inc. |
7905 Fuller Road |
Eden Prairie,
MN
55344
|
|
Correspondent Contact |
Amber Luker |
Regulation Number | 870.2060
|
Classification Product Code |
|
Date Received | 07/24/2017 |
Decision Date | 08/18/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|