Device Classification Name |
Scale, Patient
|
510(k) Number |
K904286 |
Device Name |
SCALE-TRONIX INCUBATOR SCALE MODEL:4050/MODIFIED |
Applicant |
SCALE-TRONIX, INC. |
P.O. BOX 15 |
WHEATON,
IL
60189
|
|
Applicant Contact |
E. A STANIS |
Correspondent |
SCALE-TRONIX, INC. |
P.O. BOX 15 |
WHEATON,
IL
60189
|
|
Correspondent Contact |
E. A STANIS |
Regulation Number | 880.2720 |
Classification Product Code |
|
Date Received | 08/29/1990 |
Decision Date | 10/01/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|