Device Classification Name |
Accessory, Assisted Reproduction
|
510(k) Number |
K013703 |
Device Name |
SANYO CO2 INCUBATORS, MODELS NOS. MCO-17AC, MCO-17AIC, MCO-20AIC,AND MC0-175M |
Applicant |
SANYO NORTH AMERICA CORP. |
900 N. ARLINGTON HEIGHTS RD. |
SUITE 310 |
TASCA,
IL
60143 -2844
|
|
Applicant Contact |
SACHI KATAOKA |
Correspondent |
SANYO NORTH AMERICA CORP. |
900 N. ARLINGTON HEIGHTS RD. |
SUITE 310 |
TASCA,
IL
60143 -2844
|
|
Correspondent Contact |
SACHI KATAOKA |
Regulation Number | 884.6120
|
Classification Product Code |
|
Date Received | 11/08/2001 |
Decision Date | 12/14/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|