| Device Classification Name |
Coil, Magnetic Resonance, Specialty
|
|---|
| 510(k) Number |
K053017 |
|---|
| Device Name |
MODELS HRS-63-8 AND HRS-127-8 SHOULDER ARRAY COILS |
|---|
| Applicant |
| Invivo Corporation |
| N27 W23676 Paul Rd. |
|
Pewaukee,
WI
53072
|
|
| Applicant Contact |
THOMAS SCHUBERT |
| Correspondent |
| Invivo Corporation |
| N27 W23676 Paul Rd. |
|
Pewaukee,
WI
53072
|
|
| Correspondent Contact |
THOMAS SCHUBERT |
| Regulation Number | 892.1000 |
|---|
| Classification Product Code |
|
|---|
| Date Received | 10/26/2005 |
|---|
| Decision Date | 11/16/2005 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
Radiology
|
|---|
| 510k Review Panel |
Radiology
|
|---|
| Statement |
Statement
|
| Type |
Special
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|
Predetermined Change
Control Plan Authorized |
No
|
|---|
| Recalls |
CDRH Recalls
|
|---|