510(k) K855001
K855001 is an FDA 510(k) premarket notification submitted by Seratronics, Inc. for the device "FRESENIUS HEMODIALYSIS MACHINE A1008 BSM". The FDA issued a decision of Substantially Equivalent on January 21, 1986. The device falls under product code FLC (Station, Dialysis Control, Negative Pressure Type), a Class II device regulated under 21 CFR 876.5820. Seratronics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 21, 1986
- Date Received
- December 13, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Station, Dialysis Control, Negative Pressure Type
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type