The following data is part of a premarket notification filed by Ekf-diagnostic Gmbh with the FDA for Hemo Control (optional Add Pack Hemo Control Dm).
| Device ID | K200909 |
| 510k Number | K200909 |
| Device Name: | Hemo Control (optional Add Pack Hemo Control DM) |
| Classification | System, Hemoglobin, Automated |
| Applicant | EKF-diagnostic GmbH Ebendorfer Chaussee 3 Barleben, DE 39179 |
| Contact | Andrew J. Rutter |
| Correspondent | Andrew J. Rutter EKF-diagnostic GmbH Ebendorfer Chaussee 3 Barleben, DE 39179 |
| Product Code | GKR |
| CFR Regulation Number | 864.5620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-06 |
| Decision Date | 2020-06-12 |