510(k) K922382
K922382 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "INTERMATE(R) LV ELASTOMERIC INFUSION DEVICE". The FDA issued a decision of Substantially Equivalent on Feb 5, 1993. The device falls under product code MEB (Pump, Infusion, Elastomeric), a Class II device regulated under 21 CFR 880.5725. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 5, 1993
- Date Received
- May 20, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Pump, Infusion, Elastomeric
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- HO
- Submission Type
- 510(k)