510(k) K822823
K822823 is an FDA 510(k) premarket notification submitted by Eko Scann AB for the device "HEMATOLOGY COMPUTER-INTERFACE, VISCOUNT". The FDA issued a decision of Substantially Equivalent on October 18, 1982. The device falls under product code LKM (Counter, Urine Particle), a Class II device regulated under 21 CFR 864.5200. Eko Scann AB has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 18, 1982
- Date Received
- September 21, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Counter, Urine Particle
- Device Class
- Class II
- Regulation Number
- 864.5200
- Review Panel
- HE
- Submission Type