Device Classification Name |
Coil, Magnetic Resonance, Specialty
|
510(k) Number |
K011683 |
Device Name |
NURVO 9000 ENDOCAVITARY COILS |
Applicant |
USA INSTRUMENTS, INC. |
1515 DANNER DR. |
AURORA,
OH
44202
|
|
Applicant Contact |
RONY THOMAS |
Correspondent |
USA INSTRUMENTS, INC. |
1515 DANNER DR. |
AURORA,
OH
44202
|
|
Correspondent Contact |
RONY THOMAS |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 05/30/2001 |
Decision Date | 12/10/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|