Device Classification Name |
Warmer, Infant Radiant
|
510(k) Number |
K931529 |
Device Name |
INFANT WARMER |
Applicant |
MEDIX I.C.S.A. |
CALLE 89 JOSE ARIAS 293 |
SAN MARTIN, BUENOS AIRES,
AR
B1672ACA
|
|
Applicant Contact |
CARLOS GUERRA |
Correspondent |
MEDIX I.C.S.A. |
CALLE 89 JOSE ARIAS 293 |
SAN MARTIN, BUENOS AIRES,
AR
B1672ACA
|
|
Correspondent Contact |
CARLOS GUERRA |
Regulation Number | 880.5130
|
Classification Product Code |
|
Date Received | 03/26/1993 |
Decision Date | 03/11/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|