510(k) K820575
K820575 is an FDA 510(k) premarket notification submitted by Computer Dialysis Systems, Inc. for the device "J.E.T. DIALYSIS SYSTEM". The FDA issued a decision of Substantially Equivalent on May 20, 1982. The device falls under product code FKJ (Filter, Blood, Dialysis), a Class II device regulated under 21 CFR 876.5820. Computer Dialysis Systems, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 20, 1982
- Date Received
- March 3, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Filter, Blood, Dialysis
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type