Device Classification Name |
coil, magnetic resonance, specialty
|
510(k) Number |
K201101 |
Device Name |
1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil |
Applicant |
NeoCoil, LLC |
N27 W23910A Paul Rd. |
Pewaukee,
WI
53072
|
|
Applicant Contact |
Katie Gonzalez |
Correspondent |
NeoCoil, LLC |
N27 W23910A Paul Rd. |
Pewaukee,
WI
53072
|
|
Correspondent Contact |
Katie Gonzalez |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 04/24/2020 |
Decision Date | 06/02/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|