510(k) K870656
K870656 is an FDA 510(k) premarket notification submitted by Imed Corp. for the device "IMED(R) 980C VOLUMETRIC INFUSION PUMP". The FDA issued a decision of Substantially Equivalent on October 20, 1987. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Imed Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 20, 1987
- Date Received
- February 18, 1987
- 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