510(k) K840616
K840616 is an FDA 510(k) premarket notification submitted by Advanced Bio Systems, Inc. for the device "MINI-PUMP U-100". The FDA issued a decision of Substantially Equivalent on March 30, 1984. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Advanced Bio Systems, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 30, 1984
- Date Received
- February 13, 1984
- 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