510(k) K983321
K983321 is an FDA 510(k) premarket notification submitted by Baxa Corp. for the device "MICROFUSE DUAL RATE INFUSER". The FDA issued a decision of Substantially Equivalent on October 6, 1998. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Baxa Corp. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 6, 1998
- Date Received
- September 22, 1998
- Clearance Type
- Special
- 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