510(k) K923066
K923066 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "FLO-GARD 2100 - 2M8281M". The FDA issued a decision of Substantially Equivalent on May 13, 1993. The device falls under product code LZH (Pump, Infusion, Enteral), 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
- May 13, 1993
- Date Received
- Jun 25, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Pump, Infusion, Enteral
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- HO
- Submission Type
- 510(k)