510(k) K200909
K200909 is an FDA 510(k) premarket notification submitted by Ekf-Diagnostic GmbH for the device "Hemo Control (optional Add Pack Hemo Control DM)". The FDA issued a decision of Substantially Equivalent on June 12, 2020. The device falls under product code GKR (System, Hemoglobin, Automated), a Class II device regulated under 21 CFR 864.5620. Ekf-Diagnostic GmbH has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 12, 2020
- Date Received
- April 6, 2020
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Hemoglobin, Automated
- Device Class
- Class II
- Regulation Number
- 864.5620
- Review Panel
- HE
- Submission Type