Device Classification Name |
device, spot-film
|
510(k) Number |
K802888 |
Device Name |
RAYTHEON MEDICAL IMAGING |
Applicant |
MACHLETT LABORATORIES, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
MACHLETT LABORATORIES, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 892.1670
|
Classification Product Code |
|
Date Received | 11/17/1980 |
Decision Date | 01/09/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|