510(k) K781633
K781633 is an FDA 510(k) premarket notification submitted by Extracorporeal Medical Specialities, Inc. for the device "ULTRAFILTRATION SCALE". The FDA issued a decision of Substantially Equivalent on Dec 7, 1978. The device falls under product code FIL (System, Dialysate Delivery, Single Pass), a Class II device regulated under 21 CFR 876.5820. Extracorporeal Medical Specialities, Inc. has 68 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 7, 1978
- Date Received
- Sep 21, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- System, Dialysate Delivery, Single Pass
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type
- 510(k)