510(k) K860492
K860492 is an FDA 510(k) premarket notification submitted by Nordisk Infuser System for the device "NORDISK INFUSER SYSTEM WITH PRE-FILLED CARTRIDGE". The FDA issued a decision of Substantially Equivalent on February 19, 1986. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Nordisk Infuser System has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 19, 1986
- Date Received
- February 3, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Infusion
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- HO
- Submission Type