510(k) K020103
K020103 is an FDA 510(k) premarket notification submitted by Stihler Electronic GmbH for the device "PRISMAFLO". The FDA issued a decision of Substantially Equivalent on July 24, 2002. The device falls under product code KOC (Accessories, Blood Circuit, Hemodialysis), a Class II device regulated under 21 CFR 876.5820. Stihler Electronic GmbH has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 24, 2002
- Date Received
- January 11, 2002
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessories, Blood Circuit, Hemodialysis
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type