Device Classification Name |
system, nuclear magnetic resonance imaging
|
510(k) Number |
K013344 |
Device Name |
INTERA I/T |
Applicant |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. |
472 WHEELERS FARMS RD. |
MILFORD,
CT
06460
|
|
Applicant Contact |
PETER ALTMAN |
Correspondent |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. |
472 WHEELERS FARMS RD. |
MILFORD,
CT
06460
|
|
Correspondent Contact |
PETER ALTMAN |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 10/09/2001 |
Decision Date | 12/11/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|