Device Classification Name |
System, Hemoglobin, Automated
|
510(k) Number |
K200909 |
Device Name |
Hemo Control (optional Add Pack Hemo Control DM) |
Applicant |
EKF-diagnostic GmbH |
Ebendorfer Chaussee 3 |
Barleben,
DE
39179
|
|
Applicant Contact |
Andrew J. Rutter |
Correspondent |
EKF-diagnostic GmbH |
Ebendorfer Chaussee 3 |
Barleben,
DE
39179
|
|
Correspondent Contact |
Andrew J. Rutter |
Regulation Number | 864.5620 |
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/06/2020 |
Decision Date | 06/12/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|